The US Food and Drug Administration said Friday it is extending emergency use authorization for remdesivir to all patients hospitalized for coronavirus, regardless of the severity of their disease.
The FDA originally authorized remdesivir for emergency use in May only for patients with severe coronavirus who needed help breathing with extra oxygen or mechanical ventilation. The drug has been shown to shorten recovery time for some coronavirus patients.
The FDA said clinical trials of remdesivir, including Phase 3 trials, showed a five-day course of the drug could reduce recovery time in moderately ill patients with pneumonia from Covid-19. “The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” FDA Commissioner Dr. Stephen Hahn said in a statement.
“As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease,” Dr. Merdad Parsey, chief medical officer of Gilead Sciences, said in a statement. “Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.” Veklury is the brand name for remdesivir.
An emergency authorization allows the FDA to expedite use of a coronavirus drug that has not yet received full approval. The FDA is examining data from a number of clinical trials for potential coronavirus treatment drugs.