Europe Authorizes Anti-IL-6 Receptor Biologic to Treat Severe COVID-19 Patients

Basel-based Roche announced that the European Commission (EC) had extended the marketing authorization for Actemra® / RoActemra® today to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Following the recent emergence of the new SARS-CoV-2 variant of concern, Omicron (B.1.1.529), the World Health Organization (WHO) has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.

"Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development, in a press statement.

"The totality of evidence shows that Actemra/RoActemra can benefit those suffering from severe COVID-19."

The decision from the EC today follows an accelerated assessment by the EMA's CHMP, which reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19.

Outside of the European Union, Actemra/RoActemra has been provisionally approved in Australia, authorized for emergency use in the U.S. and Ghana, and recommended by the World Health Organization to treat COVID-19.

Roche is working closely with regulatory bodies and other partners worldwide on the next steps to bring this medicine to as many people as possible.

Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide. It was the first approved anti-IL-6 receptor biologic and is available in intravenous and subcutaneous formulations to treat adult patients with moderate-to-severe active rheumatoid arthritis.

In 2020, Roche entered into several new partnerships, including Regeneron (REGEN-CoV) and Gilead, to develop, manufacture, and distribute molecules that can potentially treat and prevent COVID-19.

The Roche Group, headquartered in Basel, Switzerland, was founded in 1896 and is active in over 100 countries and employed more than 100,000 people worldwide in 2020.