FDA Grants Full Approval to Remdesivir for COVID-19

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Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.

Specifically, Veklury was approved for the treatment of patients 12 years and older, who weigh at least 88 pounds and have been diagnosed with COVID-19 and require hospitalization. Veklury, an antiviral drug, had previously been authorized by the regulatory agency under Emergency Use Authorization. Following EUA, Gilead Sciences manufacturing division went into overdrive to ensure a significant supply was available to hospitals across the United States and throughout the world. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care, Gilead said in its announcement.

FDA approval was 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 III 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 ACTT-1 trial, Veklury significantly improved time to recovery as compared to placebo by five days in the overall study population and seven days in patients who required oxygen support at baseline.  Veklury also reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation. In the overall patient population, there was a trend toward reduced mortality with Veklury at Day 29.

FDA Commissioner Stephen Hahn touted the ACTT-1 study, as well as other clinical studies that show the positive impact of Veklury on COVID-19 patients. He said the full approval of the antiviral medication is an important milestone in the ongoing pandemic.

The ACTT-1 trial results are complemented by results of two Phase III open-label trials of Veklury conducted in adult patients with severe and moderate COVID-19. The SIMPLE-Severe trial, conducted in hospitalized patients who required supplemental oxygen and who were not mechanically ventilated, found that a five-day or a 10-day treatment course of Veklury achieved similar clinical outcomes. The SIMPLE-Moderate trial, which was conducted in hospitalized patients who did not require supplemental oxygen, showed statistically improved clinical outcomes with a five-day treatment course of Veklury.

Gilead Sciences Chief Executive Officer Daniel O’Day said his company has worked relentlessly to find a solution to the COVID-19 crisis since the novel coronavirus became a global 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 U.S. that is available for all appropriate patients in need,” O’Day said in a statement.

Approval for Veklury comes less than a week after the World Health Organization reported the medication had little effect on survivability of hospitalized COVID-19 patients or decreased the need for ventilation.

Gilead Sciences suggested the WHO study was inconsistent with other studies conducted on the efficacy of remdesivir in this indication, including those the FDA used to support full approval.

In parallel with the approval, the regulatory agency also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients who are under 12 years of age, weigh less than 88 pounds and have suspected or laboratory confirmed COVID-19 for whom use of an intravenous (IV) agent is clinically appropriate.