Hospitalized coronavirus patients in the EU should find it a lot easier to access Veklury, the drug from Gilead Sciences (NASDAQ:GILD) formerly known as remdesivir. The European Commission granted conditional approval to the broad-spectrum antiviral treatment on Friday.
Now, Gilead can market Veklury throughout the EU for the treatment of COVID-19 in patients 12 years of age and older with pneumonia serious enough to require supplemental oxygen in a hospital setting.
The EU based its conditional approval on results of a study that showed severely-affected COVID-19 patients treated with Veklury recovered after 11 days compared to 15 days among those treated with a placebo. While this is better than nothing, the European Medicines Agency wants to see more evidence of efficacy before granting full approval to Gilead's drug.
While there appears to be a minor benefit that helps patients exit hospitals faster, sales of Veklury in the EU won't continue through 2021 if data Gilead needs to provide later this year fails to impress.
This December, Gilead must submit final reports from Veklury studies to the agency, including a more complete description of the drug's safety profile than we've been given so far. If the benefit-to-risk ratio doesn't add up, Veklury's conditional approval will be a short one.
We'll know more about Veklury's potential benefits soon. Next month, Gilead needs to submit final data on mortality from the study that produced positive, but underwhelming, data with regards to recovery times. The European Medicines Agency hasn't issued a specific mortality benefit threshold, but a complete lack of one could quickly result in withdrawal of Veklury's conditional approval.