Hospitalized patients with coronavirus in the EU should have much easier access to Veklury, the medicine from Gilead Sciences (NASDAQ: GOLDEN) formerly known as remdesivir. The European Commission granted conditional approval for broad-spectrum antiviral treatment on Friday.
Gilead can now market Veklury across the EU for the treatment of COVID-19 in patients 12 years of age and older with pneumonia severe enough to require supplemental oxygen in a hospital setting.
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The EU based its conditional approval on the 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 giving full approval to the Gilead medicine.
Obstacles ahead
While there appears to be a minor benefit helping patients get out of hospitals faster, Veklury sales in the EU won’t continue until 2021 if the data Gilead needs to provide later this year isn’t impressive.
This December, Gilead is due to submit final reports of Veklury’s studies to the agency, including a more complete description of the drug’s safety profile than we’ve received so far. If the benefit-risk ratio doesn’t match, Veklury’s conditional approval will be brief.
We will soon know more about the possible benefits of Veklury. Next month, Gilead needs to present final data on study mortality that produced positive, but disappointing, data regarding recovery times. The European Medicines Agency has not issued a specific mortality benefit threshold, but the complete lack of one could quickly result in the withdrawal of Veklury’s conditional approval.
