23 October 2020 - - The US Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, US-based Gilead Sciences, Inc. (NASDAQ: GILD) said.

As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19.

Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States.

The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.

In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.

Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.

This approval is based on three randomized controlled trials including the recently published, final results of the National Institute of Allergy and Infectious Diseases' (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19.

Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.

In the randomized, double-blind, placebo-controlled ACTT-1 trial, Veklury significantly improved time to recovery as compared to placebo by five days in the overall study population (10 vs. 15 days; rate ratio, 1.29; 95% CI, 1.12 to 1.49; p94% and radiological evidence of pneumonia. The primary endpoint was clinical status on Day 11 assessed on a 7-point ordinal scale.

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research.

Veklury has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19.

Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.