FDA okays first COVID-19 treatment

Henrietta Strickland
October 29, 2020

Chief scientist for the Food and Drug Administration (FDA), Denise Hinton, issued a letter of approval to Gilead Sciences, Inc. giving the company full approval to issue the drug Remdesivir-also known as Veklury-to hospitals for the treatment of all patients with COVID-19 on Oct 22.

The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.

"It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the US that is available for all appropriate patients in need", said Gilead CEO Daniel O'Day in a statement.

The agency points out the approval does not cover patients authorized to receive Veklury under an emergency use authorization issued in May.

The FDA consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing, including for products to diagnose, cure, mitigate, treat or prevent COVID-19 Coronavirus and for other critically needed products to treat symptoms of COVID-19 Coronavirus or to provide supportive care to those with COVID-19 Coronavirus. "Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic". "It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the USA that is available for all appropriate patients in need", said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. One trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated, reportedly showing a shorter recovery time compared to the placebo group.

Other reports by Click Lancashire

Discuss This Article

FOLLOW OUR NEWSPAPER