EU Approves Roche’s Treatment for Severe COVID-19

Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.

Roche announced that the European Union (EU) approved an extension of its marketing authorization for Actemra/RoActemra (tocilizumab) to include treatment of severe COVID-19 on Dec. 7, 2021. Tocilizumab can now be used as a treatment for adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Tocilizumab received an accelerated assessment from The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Just hours after CHMP issued a recommendation favoring it, the EU approved the drug’s extended marketing authorization.

“[Tocilizumab] is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development, in a company press release. “The totality of evidence shows that [tocilizumab] can benefit those suffering with severe COVID-19. Together with vaccines, other treatments and testing, [tocilizumab] forms an important piece of the care puzzle as we confront new challenges of the pandemic in Europe and around the world.”

Tocilizumab is an anti-IL-6 receptor biologic, available in both intravenous and subcutaneous formulations, that was originally used in the treatment of moderate-to-severe active rheumatoid arthritis. According to the press release, in addition to the EU, it is provisionally approved in Australia, authorized for emergency use in the United States and Ghana, and recommended by the World Health Organization (WHO) for the treatment of COVID-19.

Source: Roche