Gilead Sciences that it has submitted an application to the FDA seeking approval of its experimental antiviral Veklury (remdesivir) as a treatment for patients with COVID-19. The drug is currently available in the US under an emergency-use authorization for hospitalized patients severely ill from SARS-CoV-2 infection. According to Gilead, the current filing is the final tier of a rolling submission that was initiated in early April.
Veklury has already been approved by several regulatory authorities, including in Europe and Japan. The US filing is supported by data from phase 3 studies, including the ACTT trial conducted by the US National Institute of Allergy and Infectious Diseases, which showed that treatment with Veklury led to faster recovery times than placebo, as well as two Gilead trials, which found that a five-day or 10-day treatment duration led to similar clinical improvement. Across studies, Veklury was generally well-tolerated in both the five- and 10-day treatment groups, with no new safety signals identified.
Merdad Parsey, chief medical officer at Gilead, said that “since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations.” Last month, the company also began testing an inhaled formulation of the drug, currently administered via intravenous infusion, to enable outpatient treatment of COVID-19.
The company recently disclosed that remdesivir would be priced at $390 per vial in the US and other developed countries, with a five-day treatment course of six vials costing $2340 per patient.