EU approves Roche’s Actemra for severe COVID-19

The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours of a recommendation from its advisory committee.

Actemra (tocilizumab) has been approved for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation, a group for which the drug is already available under emergency authorisations.

Roche said in a statement that the drug has also been provisionally approved in Australia for the treatment of COVID-19. The Commission is however thought to be the first regulator to award full regulatory approval to the IL-6 inhibitor.

Actemra is widely used as a treatment for rheumatoid arthritis, but has seen a new lease of life as a COVID-19 treatment, with so much demand during the pandemic that it has outstripped supply.

Sales in the first nine months of the year rose by 30% to CHF 2.69 billion ($2.91 billion), fuelled by inclusion in treatment guidelines in many countries around the world as a COVID-19 therapy and the resolution of supply constraints. In the same period of 2019, before the pandemic, sales were CHF 1.7 billion.

EU approval was recommended by the EMA’s human medicines committee (CHMP) after looking at data from a study in more than 4,000 hospitalised adults with COVID-19 which showed that treatment with Roche’s drug on top of standard treatment with corticosteroids reduced the risk of death.

All told, 31% of patients treated with Actemra died within 28 days of treatment, compared with 35% of patients on standard treatment alone.

The results led the World Health Organization (WHO) to recommend the drug as a treatment for COVID-19 infections, and in the last few days the agency has also said IL-6 blockers like Actemra are still expected to be effective for managing patients with the emerging Omicron variant of SARS-CoV-2.

In August, the WHO and global health agency Unitaid called on Roche to ensure that supplies of  Actemra don’t just go to wealthy countries, and asked the company to license out the technology needed to make the IL-6 inhibitor to other manufacturers.

Roche said in a statement that it 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 approvals for Actemra mark a turnaround in the fortunes of the drug after initial studies reported in the early months of the pandemic yielded disappointing results.

The EU green light is also Roche’s second for a COVID-19 therapy in a matter of weeks.

Last month, it won approval from the Commission for Ronapreve (casirivimab and imdevimab) as a treatment for non-hospitalised patients with mild to moderate COVID-19 patients and for prevention of infection in people exposed to the virus.

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