Gilead gets USFDA approval for Veklury (remdesivir) to treat COVID-19

Gilead Sciences announced that the US Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalisation. Previously authorised by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the US.

In the US, Veklury is indicated for adults and paediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalisation. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

This approval is based on three randomised 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 hospitalised 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 hospitalised patients.

In the randomised, 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; p<0.001) and seven days in patients who required oxygen support at baseline (11 vs. 18 days; rate ratio, 1.31; 95% CI, 1.12 to 1.52). As a secondary endpoint, Veklury also reduced disease progression in patients needing oxygen, resulting in a significantly lower 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 reduced mortality with Veklury compared with placebo at Day 29 (11.4% vs. 15.2%, HR 0.73; 95% CI, 0.52 to 1.03). Additional mortality data from a post-hoc analysis were published in the New England Journal of Medicine on October 8, 2020.

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, conducted in hospitalised 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 (odds ratio 0.75; 95% CI, 0.51 to 1.12). The SIMPLE-Moderate trial, conducted in hospitalised patients who did not require supplemental oxygen, showed statistically improved clinical outcomes with a five-day treatment course of Veklury compared with standard of care (odds ratio 1.65; 95% CI, 1.09 to 2.48; p=0.017). The odds of improvement in clinical status with the 10-day treatment course of Veklury versus standard of care were also favourable, trending toward but not reaching statistical significance (odds ratio 1.31; 95% CI, 0.88 to 1.95).

The incidence of adverse events associated with Veklury was similar to placebo in the ACTT-1 trial. Rates of 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 occurring in at least 5% of subjects in either the Veklury 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increased (3% vs 6%), and ALT increased (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).

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 hospitalised pediatric patients under 12 years of age weighing at least 3.5 kg or hospitalised 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, and 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 paediatric patients under 12 years of age or weighing less than 40 kg has not been approved by FDA, and the safety and efficacy of Veklury for this use has not been established.