Roche said that it has initiated global phase III study and collected data on Actemra's potential utility in severe COVID-19 pneumonia patients.
The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra/RoActemra on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care.
At present, there are no studies showing safety and efficacy of Actemra in clinical treatment of COVID-19 pneumonia, and Actemra is not currently approved for this use.
Roche said it is working urgently to accelerate manufacturing capacity to maximize production of Actemra wherever possible with the goal of increasing available supply globally.
On March 12, Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 Test to detect the novel virus that causes COVID-19 disease. The test is also available in markets accepting the CE mark.
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