Gilead: FDA could extend the use of remdesivir despite mixed data

(Reuters) – The U.S. Food and Drug Administration was able to update its emergency use authorization for Gilead Sciences Inc’s (GILD.O) brakesivir of drugs to admit patients admitted to hospital with moderate COVID-19, despite mixed test results, the company’s top study said on Friday.

The FDA in May also approved sales of brake desivir on an emergency basis for patients hospitalized with severe COVID-19, the disease caused by the new coronavirus, after trial data showed that the antiviral drug helped shorten the hospital’s recovery time.

Company data published on Friday showed that a 5-day course of intravenous brake drug helped modest less seriously ill COVID-19 patients, but a 10-day course showed no benefit.

Diana Brainard, head of clinical research at Gilead, also told Reuters that the company’s formal FDA application for the drug, submitted earlier this month, seeks approval for use in all patients with hospitalized COVID-19.

The 600 patient analysis, published by the Journal of the American Medical Association, found that moderately ill patients treated with antiviral drugs for up to 5 days had a significantly higher chance of improvement in certain areas, such as whether or not they needed extra oxygen. , compared with patients receiving standard treatment.

Brainard said the clinical significance of the benefit to those patients was uncertain, due to ongoing questions about how best to measure patient outcomes other than survival.

Different test results for remdesivir raise “the question of whether the abnormalities are artifacts of study design choices, including patient populations, or whether the drug is less efficient than hoped,” according to a JAMA editorial accompanying the study.

The study in moderately ill COVID-19 patients showed that 11 days after the start of treatment 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients left the hospital.

Side effects that were more commonly seen in the brake desivir groups included nausea, low potassium levels, and headaches.

The JAMA editorial board asked important questions about the effectiveness of remdesivir, including which patients are most likely to benefit from the drug, the optimal duration of therapy, the impact of the drug on clinical outcomes, and the relative effect when combined with generic steroid treatments.

Shares of Gilead rose 45 cents to close at $ 66.50 on the Nasdaq exchange on Friday.