06.25.21

Roche’s Actemra Gains FDA Emergency-Use in Hospitalized COVID-19 Patients

Source: FirstWord

The FDA announced that it issued an emergency-use authorization (EUA) to Roche’s Actemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and paediatric patients, according to FirstWord. Specifically, the IL-6 receptor antagonist is cleared for use in people who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive 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 hospitalized COVID-19 patients. Results presented in February showed that Actemra reduced the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators 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 hospitalizations from severe forms of the disease,” remarked Levi Garraway, Roche’s head of global product development. First-quarter sales of Actemra rose 17% year-over-year to CHF 779 million ($851 million), boosted by use for treating patients with 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 hospitalized 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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