This approval is based on results emanating from three randomized controlled trials demonstrating that treatment with Veklury resulted in clinically meaningful improvements across 3 ACTT-1 trial multiple outcome assessments compared with placebo in hospitalized patients with COVID-19.

Gilead Sciences Veklury (remdesivir) Trials

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 and seven days in patients who required oxygen support. As a secondary endpoint 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 compared with placebo on Day 29.

The ACTT-1 trial results are complemented by results of two Phase 3 open-label trials of Veklury conducted in adult patients with severe and moderate COVID-19.

The SIMPLE-Severe trial was conducted in hospitalized patients who required supplemental oxygen and who were not mechanically ventilated; a five-day or a 10-day treatment course of Veklury achieved similar clinical outcomes.

The SIMPLE-Moderate trial was conducted in hospitalized patients who did not require supplemental oxygen; it showed statistically improved clinical outcomes with a five-day treatment course of Veklury compared with standard of care.

The odds of improvement in clinical status with the 10-day treatment course of Veklury versus standard of care were also favorable, trending toward but not reaching statistical significance. Based on the strength of the data from these trials Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients.

Trials’ Adverse Events

• In the ACTT-1 trial the serious adverse events (SAEs) were numerically higher in the placebo group compared with the Veklury group. Treatment discontinuation all-cause grade 3 and 4 adverse events (AEs) and laboratory abnormalities were similar across groups.
• In the SIMPLE-Severe trial the most common adverse reactions in at least 5% of subjects in either the Veklury 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increase of (3% vs 6%) and ALT increase of (2% vs 7%).
• In the SIMPLE-Moderate trial the most common adverse reaction occurring in at least 5% of subjects in the Veklury groups was nausea (7% in the 5-day group, 4% in the 10-day group).  

From the CEO of Gilead Sciences

Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences, said, “The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.”

FDA Temporary Emergency Use Authorization of Veklury for Pediatric Patients

In parallel with the FDA approval of Veklury, the FDA also issued a new Emergency Use Authorization (EUA) for the use of Veklury to treat hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg (7.7 lb); the same for hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory-confirmed COVID-19 for whom the use of an intravenous (IV) agent is clinically appropriate. This authorization is temporary and may be revoked, it also does not take the place of the formal submission, review and approval process for the use of Veklury in this patient population.

The use of Veklury in pediatric patients under 12 years of age or weighing less than 40 kg has not been approved by FDA; the safety and efficacy of Veklury for this use has not been established.  

Veklury® (remdesivir)

Veklury 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 which include: 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. Gilead is currently conducting multiple ongoing international Phase 3 clinical trials evaluating the safety and efficacy of Veklury for the treatment of COVID-19 in different patient populations, formulations and in combination with other therapies.

As announced on October 1, 2020 Gilead is now meeting real-time demand for Veklury in the United States and anticipates meeting global demand for Veklury this month as well, even in the event of potential future surges of COVID-19.

Contraindications 

Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to the product or any of its components. 

Prohost Observations  

The FDA approval of Velkury is great news for patients hospitalized with COVID-19. Gilead has done a heroic job, in record time, to make sure that the product is safe and effective. We are proud of our biotech companies and are looking forward to hearing that the FDA will approve the mRNA vaccines after they tie up their phase 3 trials which are happening at the speed of light.  

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