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EU Experts Recommend Approval of Gilead's COVID-19 Drug

By Todd Campbell – Updated Jun 25, 2020 at 2:40PM

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A key advisory team has given remdesivir a thumbs up, clearing the way to an official green light for its use in Europe.

After Gilead Sciences (GILD 0.32%) reported encouraging phase 3 clinical trial data in COVID-19 patients earlier this month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval, clearing the way for remdesivir to become the first drug specifically OK'd to treat COVID-19 in the European Union.

A woman in a lab coat speaking through a megaphone.

IMAGE SOURCE: GETTY IMAGES.

On June 1, the biotech company announced results for a trial testing remdesivir in COVID-19 patients with evidence of pneumonia, but without reduced oxygen levels. They showed that COVID-19 patients given a 5-day course of the antiviral alongside standard of care had better outcomes than those receiving standard of care alone. Specifically, more remdesivir patients scored better on a 7-point scale incorporating clinical results, such as hospital discharge and ventilator support, than patients in the control arm of the study.

The evidence of remdesivir's efficacy, which supports previously reported data, is particularly encouraging given the novel coronavirus's rapid spread, including in Europe. According to data compiled by Johns Hopkins, in Germany, Spain, France, and Italy alone, COVID-19 has killed more than 100,000 people out of more than 870,000 who have been officially diagnosed with the disease.

The EMA usually follows CHMP's guidance, suggesting an official -- albeit conditional -- green light for remdesivir is imminent. If granted, the approval will allow the drug's use in COVID-19 patients over 12 years old who have pneumonia and need oxygen support. The approval would last for one year; Gilead Sciences will need to provide EU regulators with adequate efficacy and safety data to support an ongoing approval by December. 

Gilead Sciences hasn't announced what it plans to charge for remdesivir yet, but research conducted by the Institute for Clinical and Economic Review (ICER) suggests a price of up to $5,080 per course would be acceptable to payers based on data, healthcare costs, and interactions with the company, according to Reuters. But the ICER also noted that recently published studies showed dexamethasone to have great promise against the worst symptoms of COVID-19. If further research supports that finding and the generically available, inexpensive steroid is approved as a coronavirus treatment, the ICER recommends the Gilead price remdesivir in the $2,520 to $2,800 range.

Todd Campbell owns shares of Gilead Sciences. His clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

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