Remdesivir Submitted to FDA for US Approval

Gilead has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for remdesivir for the treatment of patients with severe COVID-19.

The antiviral is currently emergency authorized in the patient population Gilead seeks approval for. The filing to raise the drug’s status to approved is part of the final tier of rolling NDA submissions initiated on April 8, 2020.

Gilead cites data from 2 randomized, open-label, multi-center phase 3 clinical studies of conducted by Gilead as well as a phase 3 randomized, placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

According to investigators of the various studies, the antiviral led to faster time to recovery compared with placebo and a 5-day or 10-day treatment duration led to similar clinical improvements.

Across studies, it was generally well-tolerated in both treatment groups, with no new safety issues singled out.

“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations,” said Merdad Parsey, MD, PhD, Chief Medical Officer for Gilead Sciences.

Remdesivir has already been approved by regulatory agencies around the world, including in the European Union. A recent panel recommendation published in The BMJ was a weak "yes" for the drug.

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity. It was originally developed for hepatitis C, where results were disappointing, but the drug was then repurposed as a potential treatment for Ebola virus disease and Marburg virus infections.

Further Coverage: Contagion Rapid Readout: A Clinical Review of Remdesivir for COVID-19

Erin K. McCreary, PharmD, BCPS, BCIDP, infectious diseases clinical pharmacist, University of Pittsburgh Medical Center, led a Rapid Readout discussion with Jason M. Pogue, PHARMD, BCPS, BCIDP, clinical professor, University of Michigan College of Pharmacy, and Matthew Davis, PharmD, infectious diseases clinical pharmacist, Ronald Reagan UCLA Medical Center, about the peer-reviewed article they coauthored on the use of remdesivir for coronavirus 2019 (COVID-19) patients.

Their article appeared in Infectious Disease and Therapy.

Remdesivir was issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) back in late April, and has been studied in COVID-19 patients who are experiencing severe respiratory issues.

The 3 providers analyzed clinical data in trials studying patients with COVID-19 taking the medication from January 1 to May 31.

In their findings, the medication was generally well tolerated. In their paper, they talked about challenges clinicians potentially face in deciding how to prioritize which patients can be treated with the medication.

In their video discussion, the clinicians go through the data from 3 remdesivir trials and offer insights on each. The medication did see mixed results depending on the patient category and trial, and the providers discuss the nuances of the studies.

For example, they touched upon a trial that was done in China. McCreary said there was no difference in time to clinical benefit or mortality rate that was seen in patients on low-flow oxygen and were administered remdesivir. One thing she noted from that trial was the use of steroids at that time.

In addition, the clinicians discuss what it is they want to see studied with the medication that has not been discovered already.