Gilead Sciences said Thursday that Veklury (remdesivir) has been approved by the FDA to treat hospitalized COVID-19 patients aged 12 years and older and weighing at least 40 kg, making it the first drug to gain full clearance in the US for the disease. The antiviral, which works by hindering the replication of SARS-CoV-2, was previously authorized by the agency for emergency use, initially for those with severe manifestations of COVID-19, and later for all hospitalized adult and paediatric patients with the infection.
CEO Daniel O’Day highlighted the “speed and rigor with which Veklury has been developed and approved in the US.” He added “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 US that is available for all appropriate patients in need.”
The approval is based on results from three randomised studies, including the Phase III ACTT-1 trial, with results recently published in the NEJM showing that Veklury plus standard care sped up recovery times by five days in the overall study population and by seven days among those who required oxygen support at baseline, compared with placebo and standard care. Veklury also reduced disease progression, and was associated with “a trend toward reduced mortality” compared with placebo. “Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalised patients,” Gilead stated.
However, earlier this month, a study coordinated by the World Health Organization (WHO) suggested Veklury had “little or no effect” on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients. The WHO called the early findings of its Solidarity trial “conclusive,” although Gilead has raised doubts about the study’s design.
Meanwhile, in parallel with the approval of Veklury, the FDA also issued a new emergency-use authorisation for the antiviral drug to treat hospitalised paediatric 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 use of an intravenous agent is clinically appropriate.