European Commission approves Actemra/RoActemra by Roche to treat severe COVID-19

Approval based on results from four phase-III studies in more than 5,500 patients

Roche yesterday announced that the European Commission has extended the marketing authorisation for Actemra/RoActemra (Tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. The decision comes after a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the urgent need for Actemra/RoActemra as a potential treatment option during the COVID-19 public health emergency, a statement from the company said.

“Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks,” said Levi Garraway, MD, PhD, Chief Medical Officer, and Head, Global Product Development, Roche.

According to the statement, the decision from the European Commission follows an accelerated assessment by the EMA’s CHMP, which reviewed results from four studies of Actemra/RoActemra in more than 5,500 patients with severe or critical COVID-19. These include the Roche-led phase III Covacta, Empacta and Remdacta trials, and the University of Oxford’s Randomised Evaluation of COVID-19 Therapy (Recovery) study, which was supported by Roche.

Outside of the European Union, Actemra/RoActemra has been provisionally approved in Australia, authorised for emergency use in the United States and Ghana, and recommended by the World Health Organization (WHO) for the treatment of COVID-19. Roche is working closely with regulatory bodies and other partners around the world on the next steps to bring this medicine to as many people as possible, the statement further noted.

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

ActemraCHMPCOVID-19 drugEMARoActemraRocheTocilizumab
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