Oct. 2 (UPI) — Gilead Sciences will resume control of the distribution of remdesivir as a COVID-19 treatment to U.S. hospitals, the Food and Drug Administration announced Thursday.
Gilead manufactures remdesivir under the name Veklury, but the FDA had taken over its distribution in May after giving emergency approval for the drug as a coronavirus treatment.
Gilead said it has since increased manufacturing capacity to meet the demand for the drug in U.S. hospitals and will soon meet capacity worldwide.
“Over the past five months, [the Department of Health and Human Services] rapidly, fairly, and equitably worked to distribute approximately 150,000 treatment courses of donated Veklury and make more than 500,000 treatment courses of the commercial drug available to help treat patients in U.S. hospitals,” HHS Secretary Alex Azar said.
“Now, federal government oversight of the allocation of Veklury is not required because the drug is no longer a scarce resource — a tribute to progress we have made against COVID-19 and to the strength of our partnerships with the private sector.”
The HHS updated its Emergency Use Authorization for the drug to reflect the new arrangement. AmerisourceBergen will continue to be the sole distributor of remdesivir in the United States.
Clinical results for the antiviral have been mixed, with one study in August showing the drug doesn’t improve outcomes in people hospitalized with moderate pneumonia caused by COVID-19.
But research published in May suggested the drug might be effective in people with severe COVID-19.
A study published by the New England Journal of Medicine found that seriously ill patients infected with the new coronavirus had an average recovery time of 11 days after receiving the drug, compared to 15 days for those given a placebo.
Researched published last month showed that remdesivir administered in combination with baricitinib — treatment for rheumatoid arthritis — can reduce the recovery time for people with COVID-19 when compared to people treated with just the antiviral.
Originally developed to treat Ebola virus, remdesivir works by slowing the production of enzymes that play a key role in the replication of viruses, including coronaviruses, according to Gilead Sciences.
