Daiichi Sankyo Submits Application for Marketing Approval of
mRNA COVID-19 Vaccine (DS-5670) in Japan

January 13, 2023

Tokyo, Japan – (January 13, 2023) – Daiichi Sankyo (TSE: 4568) today announced the submission of an application for marketing approval of DS-5670 to the regulatory authorities in Japan. DS-5670 is an mRNA vaccine, being developed against the novel coronavirus infectious disease (COVID-19) and is proposed to be used as a booster vaccine for the prevention of COVID-19.

The application is based on results of a phase 1/2/3 trial (original strain) in approximately 5,000 healthy adult and elderly subjects, who received the primary series (two doses) of an mRNA vaccine approved in Japan.

Daiichi Sankyo started prior assessment consultations for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available up to now to obtain marketing approval at an earlier date.

In addition, Daiichi Sankyo plans to move forward with the development of DS-5670 for the Omicron strain in order to respond to new variants of the coronavirus, which continue to mutate, in parallel with the development for the original strain.

Daiichi Sankyo is striving to establish mRNA-vaccine-related technologies and the production and supply system in Japan to ensure a prompt provision of vaccines in the event of outbreaks of emerging and reemerging infectious diseases, thereby contributing to protect safety and security in society and people’s health.

About DS-5670

DS-5670 is an mRNA vaccine against COVID-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo, designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus, and thus expected to have safety and desirable prevention against COVID19. Furthermore, Daiichi Sankyo is aiming for mRNA vaccines that can be distributed in the refrigerated temperature range (2-8°C).

The clinical development of DS-5670 is being conducted through the “Vaccine development project” promoted by the Japan Agency for Medical Research and Development and the “Urgent improvement project for vaccine manufacturing systems” supported by the Japanese Ministry of Health, Labour and Welfare.

About Daiichi Sankyo

aiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our worldclass science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical need. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit www.daiichisankyo.com.

Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia

January 10, 2023

  • The supplemental new drug application (sNDA) for brexpiprazole in the treatment of agitation associated with Alzheimer’s dementia has been accepted and filed by the FDA under Priority review
  • The FDA target date (PDUFA date) for completion of the review is May 10, 2023
  • FDA is currently planning to hold a Psychopharmacologic Drugs Advisory Committee
  • If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with Alzheimer’s dementia in the U.S.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review.

The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The FDA also indicated that they are currently planning to hold a Psychopharmacologic Drugs Advisory Committee meeting to discuss the application.

The sNDA submission includes data from two positive clinical phase III studies that investigated the treatment of brexpiprazole in patients with AAD. Study 331-12-283 demonstrated brexpiprazole 2 mg/day was statistically superior to placebo for the primary endpoint of mean change in Cohen-Mansfield Agitation Inventory (CMAI) Total Score from baseline to Week 12 (p < 0.05). In Study 331-14-213, treatment with brexpiprazole 2 and 3 mg/day showed statistically significant improvement compared with placebo for the primary efficacy endpoint, the mean change in CMAI Total Score from baseline to Week 12 (p < 0.05).

“Agitation associated with Alzheimer’s dementia is complex and difficult to navigate for both patients and caregivers,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “New treatments in this area are desperately needed. Our commitment to patients is unwavering as we work to provide them and their caregivers with an option to help lessen the symptoms of agitation.”

“This milestone is important in our efforts to bring patients with Alzheimer’s dementia and their caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of the disease,” said Johan Luthman, executive vice president, Lundbeck Research & Development.

New Drug Application of Ensitrelvir Fumaric Acid, a Therapeutic Drug for COVID-19 Accepted for Review in South Korea

January 4, 2023

OSAKA, Japan, January, 4, 2023 – OSAKA, Japan, January, 4, 2023 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D., hereafter “Shionogi”) announced that its partner Ildong Pharmaceutical Co., Ltd. (Head Office: Seoul, South Korea; Vice Chairman and Chief Executive Officer: Yun Paul Woongsup, hereafter “Ildong”) who has been sub-Licensed South Korean rights to Ensitrelvir Fumaric Acid (development number: S-217622, hereafter “ensitrelvir”), has filed a New Drug Application (NDA) with the MFDS (Ministry of Food and Drug Safety) for the indication of SARS-CoV-2 infection, and this application has been accepted for review by MFDS.

Following the approval of ensitrelvir in Japan on November 22, 20221, which was based on the data from the Asian Phase 2/3 clinical trials that SHIONOGI have been conducting, mainly in Japan, Ildong has been in discussions with the MFDS and the Korean Disease Control and Prevention Agency (KDCA) in order to obtain approval in South Korea2. Accordingly, Ildong has now submitted a conditional approval application to MFDS on January 3, 2023, which was accepted for review. Shionogi group will continue to work closely with Ildong to provide the necessary support for approval and commercial launch in South Korea.

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not only conducting research and development of novel therapeutics, but we are also working towards total care for infectious diseases, through building awareness, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as treating the infection itself. As SARS-CoV-2 continues to have a major impact on people’s lives and to represent a global threat, we will seek to contribute to re-establishing the safety and security of society by developing new products and services to address this pandemic. We will continue to pursue global registration, including working with the Medicines Patent Pool to provide access to low- and middle-income countries (LMICs), and to expand and strengthen our manufacturing and global supply chain, in parallel with accumulating additional evidence on efficacy and safety.

About Ensitrelvir Fumaric Acid

Ensitrelvir (Code No.: S-217622), an antiviral drug for COVID-19 currently approved under the emergency regulatory approval system in Japan, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. Ensitrelvir is the first antiviral agent to show both clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, in the Phase 3 part of the Phase 2/3 study conducted during the Omicron-dominant phase of the epidemic 3. Currently, the Phase 2b/3 part of the Phase 2/3 study targeting SARS-CoV-2 infected persons with asymptomatic/mild symptoms only is being conducted in Asia, mainly in Japan. With regard to safety, ensitrelvir was well tolerated, and there were no treatment-related serious adverse events or deaths in the study. The most common treatment-related adverse events were transient decreases in high-density lipoprotein and increases in blood triglycerides, as observed in previous studies. A global Phase 3 trial (SCORPIO-HR study 4 ) in non-hospitalized SARS-CoV-2 infected patients is ongoing. In addition, a global Phase 3 trial (STRIVE study 5 ) for hospitalized SARS-CoV-2 infected patients is scheduled to initiate soon. An onset prevention study for household members living with SARS-CoV-2 infected individuals and a pediatric study for children under the age of 12 are also in preparation.

Takeda’s EXKIVITY® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

January 11, 2023

– EXKIVITY is the First Category-1 Innovative Drug Approved for Takeda China Following a Phase 2 Global Pivotal Study

– Approval Based on Data from the Phase 1/2 Clinical Trial Demonstrating EXKIVITY’s Clinical Benefit and Durable Responses in EGFR Exon20 Insertion+ NSCLC

– Results Demonstrated a Confirmed Overall Response Rate (ORR) of 28% and Median Duration of Response (DoR) of 15.8 Months per Independent Review Committee (IRC)

OSAKA, Japan and CAMBRIDGE, Massachusetts [January 11, 2023] – Takeda (TSE:4502/NYSE:TAK) today announced that EXKIVITY® (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China. EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA’s Breakthrough Therapy program. Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

“The approval of EXKIVITY in China for patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC was only possible through dedicated collaboration and support from the NMPA and the Chinese government,” said Awny Farajallah, Head, Global Medical Affairs Oncology, Takeda. “Lung cancer is a devastating disease, and we know the discovery and delivery of precision medicines like EXKIVITY to target cancer types that are hard-to-treat have the potential to improve patient outcomes. We are thrilled to introduce EXKIVITY in China as the second lung cancer therapy from Takeda and remain committed to research and development to meet the needs of this patient community.”

Lung cancer is the most commonly diagnosed cancer in China, and NSCLC accounts for approximately 85% of all lung cancer cases in the country.1 Of those patients diagnosed with EGFR-mutated NSCLC in China, up to 10% harbor Exon20 insertions.2-7 Despite this prevalence, patients in China have lacked a targeted treatment option designed to address cancers driven by these mutations.

“Since the discovery of EGFR mutations nearly twenty years ago, patients with Exon20 insertions have been waiting for a targeted therapy to treat their disease,” said Sean Shan, President of Takeda China. “The approval of EXKIVITY in China is a remarkable breakthrough, demonstrating the strong commitment of the Chinese government to encourage and accelerate the introduction of innovative therapies. EXKIVITY offers a targeted, oral therapy to a population that has been historically underserved, and this approval brings us one step closer to defeating this complex and heterogeneous disease for patients in this region.”

This approval is based on the results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results demonstrated a confirmed ORR of 28% per IRC as well as a median DoR of 15.8 months per IRC, a median overall survival (OS) of 20.2 months and a median progression-free survival (PFS) of 7.3 months per IRC. The most common treatment-related adverse reactions (TRAEs) were diarrhea (92%), rash (46%), paronychia (38%) and decreased appetite (37%).

About EXKIVITY (mobocertinib)

EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

EXKIVITY is currently approved in the United States, Great Britain, Switzerland, South Korea, Australia and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

For more information about EXKIVITY, visit www.EXKIVITY.com. For the Prescribing Information, including the Boxed Warning, please visit https://takeda.info/Exkivity-Prescribing-Information.

About EGFR Exon20 Insertion+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.9, 10 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.2-6 This disease carries a worse prognosis than other EGFR mutations, as EGFR TKIs – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.


QTc Interval Prolongation

Heart rate-corrected QT (QTc) interval prolongation, including resultant life-threatening arrhythmias, such as Torsades de Pointes, occurred in patients treated with mobocertinib.

A concentration-dependent QTc interval prolongation of approximately 12.7 msec (90% CI: 8.69, 16.8) was observed at the steady-state Cmax following 160 mg daily doses based on an analysis of data from 194 patients with advanced solid malignances.

Clinical trials of mobocertinib did not enroll patients with baseline QTc greater than 470 msec. Assess QTc and electrolytes at baseline and correct abnormalities in sodium, potassium, calcium, and magnesium prior to initiating mobocertinib. Monitor QTc and electrolytes periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation, such as in patients with congenital long QTc syndrome, heart disease, electrolyte abnormalities, or those who are taking medicinal products known to prolong the QTc interval. Avoid concomitant use of medicinal products which are known to prolong the QTc interval. Avoid concomitant use of strong or moderate CYP3A inhibitors with mobocertinib, which may further prolong the QTc interval. Permanently discontinue mobocertinib in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Interstitial Lung Disease/Pneumonitis

Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis have occurred in patients treated with mobocertinib.

Withhold mobocertinib for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation and diagnosis confirmation. Permanently discontinue mobocertinib if ILD/pneumonitis is confirmed.

Cardiac Toxicity

Cardiac failure (including congestive cardiac failure, decreased ejection fraction, and cardiomyopathy) has occurred in patients treated with mobocertinib.

Mobocertinib can cause QTc prolongation resulting in Torsades de Pointes.

Atrial fibrillation (1.3%), ventricular tachycardia (0.3%), first degree atrioventricular block (0.7%), second degree atrioventricular block (0.3%), left bundle branch block (0.3%), supraventricular extrasystoles (0.3%) and ventricular extrasystoles (0.3%) also occurred in patients receiving mobocertinib. The causality of these events to mobocertinib has not been established.

Conduct cardiac monitoring, including assessment of left ventricular ejection fraction at baseline and during treatment. Patients who develop signs and symptoms consistent with cardiac failure should be treated as clinically indicated. Withhold, reduce the dose, or permanently discontinue mobocertinib based on the severity.


In clinical studies, most patients experienced mild to moderate diarrhea. Diarrhea can be severe or life threatening. The median time to first onset of diarrhea was five days but could occur as soon as 24 hours after administration of mobocertinib. Diarrhea is usually transient and had a median time to resolution of three days. Prolonged diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment.

Early and compliant diarrhea management such as prescribed anti-diarrheal medicinal products (e.g., loperamide), diet, adequate fluid intake (~2L clear liquids per day), and patient education is recommended. Instruct patients to have anti-diarrheal medicinal products (e.g., loperamide) readily available. Begin anti-diarrheal treatment at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. In mobocertinib clinical trials where loperamide was used as the antidiarrheal, the dosage regimen for loperamide was 4 mg at the first bout of diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours; daily dose of loperamide did not exceed 16 mg. If using loperamide as the antidiarrheal treatment, refer to loperamide product labeling for additional information.

If diarrhea does not improve or additional signs or symptoms are reported, standard medical practice intervention, including other anti-diarrheal medications, are recommended. Antidiarrheal prophylaxis may be considered as needed. Monitor electrolytes and instruct patients to increase fluid and electrolyte intake as needed. No dose modification is necessary unless the patient does not tolerate mobocertinib or the symptoms recur, or the diarrhea doesn’t resolve with medical intervention. Interrupt mobocertinib and reduce subsequent doses if severe diarrhea occurs.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, mobocertinib can cause fetal harm when administered to pregnant women.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with mobocertinib and for one month following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with mobocertinib and for one week following the final dose of mobocertinib.

Takeda’s Commitment to Oncology

At Takeda Oncology, we are united by our aspiration to cure cancer and motivated every day to work harder for patients with limited or ineffective treatment options. Our agile structure and deep in-house expertise are complemented by a network of partnerships that optimize our ability to research, develop and deliver transformative medicines to people living with cancer. Building on decades of leadership in oncology and a portfolio of approved medicines for hematologic cancers and solid tumors, we are advancing a cutting-edge pipeline focused on the power of innate immunity. With inspiration from patients and innovation from everywhere, our goal is to introduce new classes of immunotherapies that can lead to deep, durable responses so that more patients can benefit from – and have access to – innovative medicines.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

New SATREPS Projects for FY 2022 under AMED International Collaborative Research Program

Japan Agency for Medical Research and Development (AMED, President: MISHIMA Yoshinao) announced the provisional selection *1 of two new projects in the Infectious Diseases Control research area concerning “Research on measures to address infectious diseases control attuned to the needs of developing countries” for the Fiscal Year 2022 Science and Technology Research Partnership for Sustainable Development (SATREPS) program under AMED’s International Collaborative Research Program.

The SATREPS is a Japanese government program that promotes international joint research. The program has been structured as a collaboration among the Japan Agency for Medical Research and Development (AMED), the Japan Science and Technology Agency (JST) and the Japan International Cooperation Agency (JICA), supported by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and the Ministry of Foreign Affairs (MOFA). Based on the needs of developing countries, AMED and JICA cooperate to promote international joint research targeting global issues with an objective of future utilization of research outcomes through collaboration with ODA. The aim of the program is to acquire new knowledge and technology that lead to the resolution of global issues and the advance of science and technology, and through this process, to create innovations. International joint research under this program also aims to enhance the research and development capabilities of developing countries, and to help create sustainable research systems which could address and resolve issues related to Sustainable Development Goals (SDGs).

For FY2022, AMED called for project proposals from researchers in Japan in the Infectious Diseases Control research area and began to accept proposals on September 7 th, 2021. A total of 19 eligible proposals was received by the close of applications on November 8 th, 2021. Evaluation committee reviewed the proposal documents with ex-ante evaluation criterias including ODA perspectives established by the committee. AMED provisionally selected 2 new projects based on the committee evaluation results and will begin the support after the conclusion of contracts.

The SATREPS*2 programs in other three research areas—Environment/Energy, Bioresources, and Disaster Prevention and Mitigation are managed by a collaboration of JST and JICA, supported by MEXT and MOFA.*1 Provisional selection:Before starting a project , an international agreement needs to be concluded between MOFA and the government of the developing country regarding implementation of the project, followed by an agreement on the details of Technical Cooperation between JICA and the research counterpart(s) in the developing country. However, depending on the situation in the developing country or the result of discussion of details with the research counterpart, a project may result in modifications or even termination. For this reason, the status of these projects at this stage is “provisional selection”.*2 SATREPS: Science and Technology Research Partnership for Sustainable Development “Project for Integrated Research and Development towards Control and Elimination of Schistosomiasis”Republic of Kenya
(HAMANO Shinjiro, Professor, Department of Parasitology, Institute of Tropical Medicine, Nagasaki University)“Project for malaria and neglected parasitic diseases control and elimination using advanced research technique, communication tools and eco-health education”Lao People’s Democratic Republic
(IWAGAMI Moritoshi, Chief, Department of Tropical Medicine and Malaria Research Institute, National Center for Global Health and Medicine)

* Projects are listed in alphabetical order based on the name of the principal investigator.


Department of International Strategy
Japan Agency for Medical Research and Development (AMED)
1-7-1 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan
Tel: 03-6870-2216
Fax: 03-6870-2240

Chugai’s Actemra Approved for Additional Indication of SARS-CoV-2 Pneumonia in Japan

Jan 21, 2022

The approval is based on the results of several clinical studies in hospitalized patients with COVID-19.

TOKYO, January 21, 2022 — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare for the humanized anti-human IL-6 receptor monoclonal antibody, “Actemra® Intravenous Infusion 80 mg, 200 mg, and 400 mg” [generic name: tocilizumab (genetical recombination)] for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention). The approval came one month after the application for the additional indication on December 13, 2021.

“We are very pleased that Actemra, created by Chugai, has become a new treatment option for SARS-CoV-2 pneumonia. Clinical studies demonstrated that Actemra reduced the mortality rate in patients with SARS-CoV-2 infection,” said Chugai’s President and CEO, Dr. Osamu Okuda. “With the rapid spread of SARS-CoV-2 infection caused by Omicron strain, an increase is expected in the number of patients who become severely ill and develop pneumonia requiring oxygen intervention. We hope that Actemra will play a role for the better prognosis of patients with severe, potentially life-threating pneumonia.”

This approval is based on the results from clinical studies evaluating Actemra in hospitalized patients, including an investigator-initiated, randomized, open-label, platform overseas study (RECOVERY study), three placebo-controlled, randomized, double-blind, multicenter global phase III studies conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study), and a single-arm, multicenter phase III study in Japan (J-COVACTA study).

Actemra has been approved in the European Union, authorized for emergency use in the United States, and recommended by the World Health Organization for the treatment of COVID-19.

Package insert information *excerpt of revised part

Indications: SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention)

Dosage and administration: The usual adult dosage is a single intravenous infusion of 8 mg/kg tocilizumab (genetic recombination), in combination with corticosteroids. If symptoms do not improve, an additional single dose of 8 mg/kg tocilizumab (genetic recombination) may be administered 8 hours or more after the end of the initial administration.

About Actemra

Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June, 2005, the intravenous injection is approved for six indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, and adult Still’s disease. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.