Gilead’s Veklury (Remdesivir) Receives FDA Approval as the First and Only Treatment for COVID-19 in the U.S. Amid Global Cases Surpassing 41.96 Million

October 23, 2020 News /BioValleyBIOON/ -- Currently, the COVID-19 pandemic is still spreading rapidly worldwide. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport, as of 9:00 on October 23, 2020, the global cumulative confirmed cases exceeded 41.96 million, with over 1.14 million deaths.

Recently, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for hospitalized patients with COVID-19. As an antiviral agent, Veklury inhibits the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.

Previously,FDAVeklury has been granted Emergency Use Authorization (EUA) for the treatment of COVID-19. Veklury is now the first and only approved COVID-19 therapeutic in the United States,Clinical TrialIt can reduce the recovery time of hospitalized COVID-19 patients by 5 days. After early investments rapidly expanded production capacity to increase supply, the drug is now widely used in hospitals across the United States.

In the United States, Veklury is indicated for adult and pediatric patients (12 years of age and older, weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in hospitals or healthcare settings capable of providing acute care comparable to that provided in hospitalized patients. Veklury is contraindicated in patients with a history of hypersensitivity to Veklury or any of its components.

This approval is based on three randomized controlled trials, including the final results of the recently published Phase 3 ACTT-1 trial, a double-blind, placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The data demonstrated that, among hospitalized patients with COVID-19, treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo. Given the strength of these data, Veklury has become the standard of care for hospitalized patients with COVID-19.

In the randomized, double-blind, placebo-controlled ACTT-1 trial, Veklury significantly shortened time to recovery compared with placebo: by 5 days in the overall study population (10 days vs. 15 days; rate ratio, 1.29; 95% CI, 1.12–1.49; P<0.001) and by 7 days among patients who required oxygen support at baseline (11 days vs. 18 days; rate ratio, 1.31; 95% CI, 1.12–1.52). As a secondary endpoint, Veklury also reduced disease progression in patients requiring oxygen support, thereby significantly lowering the incidence of new mechanical ventilation or ECMO (13% vs. 23%; 95% CI, −15 to −4). In the overall patient population, there was a trend toward lower mortality in the Veklury group than in the placebo group by day 29 (11.4% vs. 15.2%; hazard ratio, 0.73; 95% CI, 0.52–1.03). Additional mortality data from post hoc analyses were published in the New England Journal of Medicine on October 8, 2020.

The results of the ACTT-1 trial were complemented by findings from two open-label trials of Veklury conducted in adult patients with severe and moderate COVID-19. The SIMPLE-Severe trial, which treated hospitalized patients requiring supplemental oxygen but not mechanical ventilation, found that 5-day and 10-day courses of Veklury yielded similar clinical outcomes (odds ratio=0.75; 95% CI: 0.51 to 1.12). The SIMPLE-Moderate trial, conducted in hospitalized patients not requiring supplemental oxygen, demonstrated a statistically significant improvement in clinical outcomes with a 5-day course of Veklury compared to standard care (odds ratio=1.65; 95% CI: 1.09–2.48; p=0.017). Compared with standard care, a 10-day course of Veklury also showed a high likelihood of improved clinical status, trending toward but not reaching statistical significance (odds ratio=1.31; 95% CI: 0.88–1.95).

Concurrent with the approval of Veklury, the FDA issued a new Emergency Use Authorization (EUA) for the treatment of hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg, or hospitalized pediatric patients weighing from 3.5 kg to less than 40 kg with suspected or laboratory-confirmed COVID-19, for whom intravenous (IV) administration is appropriate. This authorization is temporary, may be revoked, and does not replace 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 yet been approvedFDAapproval, and the safety and efficacy of Veklury for this indication have not been established. (Bioon.com)

Original Source: U.S. Food and Drug Administrationapproves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19