Gilead says FDA could expand eligibility of coronavirus patients for remdesivir

pharmafile | August 24, 2020 | News story | Sales and Marketing FDA, Gilead 

The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead.

Currently, the FDA guidelines state that the treatment can be given to patients experiencing severe symptoms from coronavirus. Recent studies by Gilead show that a five-day course of intravenous remdesivir modestly helped less severe cases of COVID-19, but a 10-day course did not show much benefit. This study involved 600 patients and was published in the Journal of the American Medical Association; the improvement shown by patients on a remdesivir treatment was that some required less supplemental oxygen.

Overall, the study showed that 11 days after treatment, 65% of the 10-day patients on the drug and 70% of the five-day patients left the hospital compared to 60% of those in standard care. The reported side effects included headache, nausea and low potassium levels.

The Head of Clinical Research at Gilead, Diana Brainard, told Reuters last month that the company has requested general approval for the drug, and submitted its updated data last month.

If granted general approval, the drug will go under the brand name Veklury. Due to the US government buying up all of the supply of remdesivir, the company has signed deals with Pfizer and Hikma to make the drug available around the world. Recently, a bipartisan group of US senators has asked the government to allow other companies to make remdesivir in the US to increase its availability and lower its price through competition.

Conor Kavanagh

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