Genentech, a Roche company, has secured the US Food and Drug Administration (FDA) approval for Phase 3 clinical trial intravenous Actemra (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia.

The company will conduct the randomised, double-blind, placebo-controlled study in collaboration with the biomedical advanced research and development authority (BARDA) to evaluate the safety and efficacy of Actemra.

Actemra is the first humanised interleukin-6 (IL-6) receptor antagonist intended for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults, who already used one or more disease-modifying antirheumatic drugs (DMARDs).

Genentech chief executive officer Alexander Hardy said: “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enrol as quickly as possible.

“Conducting this clinical trial in partnership with BARDA and providing Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS, are important examples of how the U.S. government, the biotechnology industry and healthcare communities are working together in response to this public health crisis.”

Genentech is supporting the US COVID-19 response efforts

Genentech said that several independent clinical trials have globally evaluated the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia.

However, the new Phase 3 trial is crucial, as there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19. Actemra is not currently approved for this use by the FDA.

The company claimed that to further support the US COVID-19 response efforts, it will provide 10,000 vials of Actemra to the US Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS).

In addition, it has also been working with distributors to manage product supply, and enable distribution partners to quickly fill orders to address patient needs.