Chugai Pharmaceutical: Files for further indication of Actemra for COVID-19 pneumonia in Japan
Chugai files additional indication request from Actemra for COVID-19
Pneumonia in Japan
- The application was filed on the basis of the results of several clinical studies in hospitalized patients with COVID-19[FEMININE.
TOKYO, 13 décembre 2021 —Chugai Pharmaceutical Co., Ltd.(TOKYO : 4519) a annoncé avoir déposé des demandes réglementaires auprès du ministère de la Santé, du Travail et du Bien-être pour l’anticorps monoclonal humanisé anti-récepteur de l’IL-6 humain, « Actemra® Infusion intraveineuse 80 mg, 200 mg et 400 mg” [generic name: tocilizumab (genetical recombination)] for the treatment of COVID-19 pneumonia.
“The spread of the COVID-19 vaccination and the approval of several therapeutic drugs have played a major role in measures against the novel coronavirus. On the other hand, with the emergence of mutant strains such as the Omicron strain, the infection status remains to be determined. unpredictable. In severe cases, symptoms can quickly worsen and cause severe and life-threatening pneumonia. We will work closely with the Japanese health authority to administer Actemra to patients with COVID-19 pneumonia as soon as possible, ”said Chugai President and CEO Dr Osamu Okuda.
This request is based on the results evaluating Actemra in hospitalized patients in an open, randomized, foreign, investigator-initiated study (RECOVERY study), three global phase III, placebo-controlled, randomized, duplicate studies blind, multicenter conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study), and a phase III, single-arm, multicenter study in Japan (J-COVACTA study).
The Actemra cohort of the RECOVERY study evaluated the efficacy and safety of Actemra in combination with standard care (Actemra group) versus standard care only (standard care group) in 4,116 hospitalized adult patients with COVID -19 characterized by hypoxia and systemic inflammation. The Actemra group showed a significant reduction in the mortality rate at day 28, primary endpoint, compared to the standard care group (Actemra group: 31%, standard care group: 35%, ratio rate: 0, 85, 95% confidence interval (CI): 0.76 -0.94, p = 0.0028). The proportion of patients discharged on day 28 was also higher in the Actemra group (Actemra group: 57%, standard care group: 50%, rate ratio: 1.22, 95% CI: 1.12 to 1.33 , p
Actemra has been approved in the European Union, cleared for emergency use in the United States and Ghana, and recommended by the World Health Organization for the treatment of COVID-19.
Roche Actemra / RoActemra Receives Emergency Use Clearance From US FDA For Treatment Of COVID-19 In Hospitalized Adults And Children (Roche press release issued June 25, 2021) https://www.roche.com/media/releases/med-cor-2021-06-25.htm
Chugai provides update on Actemra’s phase III COVACTA study in hospitalized patients with severe pneumonia associated with COVID-19 (July 29, 2020) https://www.chugai-pharm.co.jp/english/news/detail/20200729151500_752.html
Roche’s EMPACTA phase III study showed that Actemra / RoActemra reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19-associated pneumonia (Roche press release issued September 18 2020) https://www.roche.com/media/releases/med-cor-2020-09-18.htm
Results of the phase III clinical study in Japan for Actemra in pneumonia associated with COVID-19 (February 9, 2021) https://www.chugai-pharm.co.jp/english/news/detail/20210209150000_803.html
Chugai provides update on phase III REMDACTA study of Actemra Plus Remdesivir in patients with severe COVID-19 pneumonia (March 11, 2021) https://www.chugai-pharm.co.jp/english/news/detail/20210311150000_808.html
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, intravenous injection is approved for six indications in Japan: Castleman??s, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy and Still’s disease in adults. 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 around the world.
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Chugai Pharmaceutical Co. Ltd. published this content on December 13, 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on December 13, 2021 08:15:11 AM UTC.
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