COVID-19: Chugai / Roche, Actemra Phase III study commenced: FDA / a clinical trial with ASPR
April 08, 2020
COVID-19: Chugai / Roche
Chugai will conduct a Japanese phase III clinical trial of Actemra® for COVID-19 pneumonia.
Actemra®:
Chemical for intravenous drip. Generic name: tocilizumab (genetical recombination)
It is a humanized anti-human IL-6 receptor monoclonal antibody.
Overseas, Roche has announced a Phase III clinical trial (COVACTA study) in approximately 330 inpatients with severe COVID-19 pneumonia worldwide (including the United States, Canada and Europe).
Study the safety and efficacy of Actemra in combination with standard medical measures.
Roche:
Phase III clinical trial of Actemra / RoActemra started in hospitalized patients with severe COVID-19 pneumonia (March 24, 2020)
https://www.chugai-pharm.co.jp/news/detail/20200324170000_961.html
Genentech:
Actemra Receives FDA Approval from Genentech for Clinical Study in Patients with Severe COVID-19 Pneumonia (March 24, 2020)
https://www.chugai-pharm.co.jp/news/detail/20200324170001_962.html
News Release | Chugai Pharmaceutical
https://www.chugai-pharm.co.jp/news/detail/20200408170000_969.html
Roche – Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
Basel, 19 March 2020-
Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with
the Biomedical Advanced Research and Development Authority (BARDA),
a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR),
to evaluate the safety and efficacy of Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.