Gilead Files NDA for Remdesivir as COVID-19 Treatment

Gilead Sciences announced yesterday that it has filed a new drug application (NDA) with the FDA, seeking approval for remdesivir for the treatment of COVID-19 patients.

Remdesivir, marketed as Veklury, is the only antiviral to date to receive an Emergency Use Authorization from the FDA for the treatment of COVID-19 patients. The investigational drug has also been conditionally approved in multiple countries.

The California drugmaker said it began a rolling NDA submission to the FDA on April 8 — which allows sponsors to submit completed sections of their applications for review rather than waiting to submit a full application.

The remdesivir NDA is supported by results from two phase 3 trials. One trial, conducted by the NIH’s National Institutes of Allergy and Infectious Diseases, found that the treatment led to a faster recovery compared with a placebo. Patients treated with remdesivir had a median time to recovery of 11 days compared to 15 days for those in the placebo group.

The second trial, conducted by Gilead, found that patients on a 5-day dosing regimen saw clinical improvements similar to those on a 10-day treatment schedule (DID, April 30).

Gilead’s Chief Medical Officer Merdad Parsey called the NDA filing an “important milestone” as the company “works around the globe to address the treatment needs of patients with COVID-19.”

Gilead expects to be able to meet international demand for remdesivir in October due to improvements in its processes and an expanded manufacturing network (DID, Aug. 10). — Jordan Williams