Roche's Actemra gains FDA emergency-use nod in hospitalised COVID-19 patients

The FDA announced that it issued an emergency-use authorisation (EUA) to Roche's Actemra (tocilizumab) for the treatment of COVID-19 in hospitalised adults and paediatric patients. Specifically, the IL-6 receptor antagonist is cleared for use in people who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The EUA is based on findings from four studies, including the RECOVERY trial, which included more than 4000 hospitalised COVID-19 patients. Results presented in February showed that Actemra lowered the risk of death through 28 days of follow-up and reduced the amount of time patients remained hospitalised. The risk of patients progressing to invasive mechanical ventilation or death through 28 days of follow-up was also decreased.

"Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease," remarked Levi Garraway, Roche's head of global product development. First-quarter sales of Actemra, which is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis, rose 17% year-over-year to CHF 779 million ($851 million), boosted by use in treating severe COVID-19-associated pneumonia, having surged nearly a third in 2020 to CHF 2.9 billion ($3.2 billion).

Last year, the FDA expanded the EUA for Gilead Sciences' Veklury (remdesivir) to include treatment of all hospitalised patients with COVID-19, regardless of the severity of their disease, with the antiviral securing full approval shortly afterwards. A later study found that the addition of Actemra to Veklury was no better than Veklury alone at improving hospital discharge rates in patients with severe COVID-19 pneumonia.

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