EMA Speeds Review of Remdesivir for Conditional Authorization

The European Medicines Agency (EMA) said it is giving a fast-track review to a conditional marketing authorization request from Gilead Sciences for using remdesivir to treat COVID-19 patients.

The agency said it may grant the authorization within weeks, as it has already completed a review of preliminary trial data and supporting data from compassionate use of the drug. An opinion could be issued shortly, depending on the robustness of that data and whether further information is needed to support the evaluation, the EMA said.

The FDA granted remdesivir an Emergency Use Authorization on May 1 for treatment of hospitalized COVID-19 patients with severe disease, based on positive data from two studies. That authorization allows the antiviral to be given intravenously to treat suspected or lab-confirmed COVID-19 in adults and children who require oxygen therapy or more intensive-breathing support or who have low blood-oxygen levels (DID, May 4).

India, Japan and South Korea have also issued emergency authorizations for the drug for treatment of severe COVID-19 patients.

A benefit-risk assessment of remdesivir by the UK’s Drug Safety Research Unit, which looked at trial data from peer reviewed journals as well as unpublished trial data, concluded that the drug’s benefit-risk profile is favorable, though there are some unanswered questions about its safety (DID, June 9).

In additional positive news for the antiviral, a National Institute of Allergy and Infectious Diseases (NIAID) study of the drug in rhesus macaques with COVID-19 found that the treated monkeys had lower viral loads in their lungs and less lung damage.

“Although the rhesus macaque model does not represent the severe disease observed in a proportion of COVID-19 patients, our data support early remdesivir treatment initiation in COVID-19 patients to prevent progression to pneumonia,” the researchers said. — James Miessler