(Reuters) – The U.S. Food and Drug Administration could update its emergency use authorization for Gilead Sciences Inc’s GILD.O drug remdesivir to include patients hospitalized with moderate COVID-19, despite mixed trial results, the company’s top research executive said on Friday.
The FDA in May okayed sales of remdesivir 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 their hospital recovery time.
Company data published on Friday showed that a 5-day course of intravenous remdesivir modestly helped less severely ill COVID-19 patients, but a 10-day course did not show a 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 hospitalized patients with COVID-19.
The 600-patient analysis, published by the Journal of the American Medical Association, found that moderately ill patients treated with the antiviral drug for up to 5 days had significantly higher odds of improvement in certain areas, such as whether or not they needed supplemental oxygen, compared to patients given standard treatment.
Brainard said the clinical importance of the benefit for those patients was uncertain, due to continued questions about how best to measure patient outcomes other than survival.
Differing trial results for remdesivir raise “the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” according to a JAMA editorial accompanying the study.
The study in moderately ill COVID-19 patients showed that 11 days after starting treatment, 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients had left the hospital.
Side effects seen more frequently in the remdesivir groups included nausea, low blood potassium levels, and headache.
The JAMA editorial said important questions remain regarding the efficacy of remdesivir, including which patients are most likely to benefit from the drug, the optimal duration of therapy, the drug’s impact on clinical outcomes, and its relative effect if combined with generic steroid treatments.
Reporting by Deena Beasley; Editing by Nick Tattersall, Sonya Hepinstall and Diane Craft