Roche testing with BARDA Actemra’s potential utility in severe COVID-19 pneumonia patients. Working on availability of COVID 19-tests.

Roche said Tuesday it started testing Actemra (tocilizumab) with the Biomedical Advanced Research and Development Authority (BARDA)on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care.
BARDA is a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR).

Roche said this is the first global study of Actemra/RoActemra in this setting. In addition to the trial, Roche said it is also carefully following independently-led clinical trials, on multiple medicines including Actemra, that are taking place around the world.

At the moment, there are no robust, well-controlled 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.

Despite some of the supply and logistics challenges due to COVID-19, Roche said it has been able to continue to deliver life-saving medicines to patients around the world, thanks to the resilience of its global network. “Currently, we continue to see limited disruption, and are continually monitoring the situation,” Roche said.

With the announcement of new clinical trials, and a potential increase in demand for Actemra, Roche is said it is working urgently to accelerate manufacturing capacity to maximize production of Actemra wherever possible with the goal of increasing available supply globally.

Roche noted it received on March 12, FDA Emergency Use Authorization for the cobas SARS-CoV-2 Test to detect the novel virus that causes COVID-19 disease.