Gilead Sciences said Friday that the European Commission granted conditional approval to Veklury (remdesivir) for the treatment of SARS-CoV-2 infection. The company noted that the clearance, which was based on a rolling review that began in April, follows a positive opinion on the application in late June from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Specifically, Veklury is indicated for the treatment of COVID-19 in adults and adolescents, who are aged 12 years and older and weighing at least 40 kg, with pneumonia requiring supplemental oxygen. The approval was supported by results from the ACTT trial, led by the US National Institute of Allergy and Infectious Diseases, which showed that moderate-to-severe COVID-19 patients who received the nucleotide analogue saw their recovery times shortened by about four days compared to placebo, from 15 to 11 days, with particular benefit seen in those who required supplemental oxygen.
Gilead recently disclosed that Veklury will be priced at $390 per vial in developed countries, with a five-day treatment course of six vials costing $2340 per patient. The company noted at the time that the fixed price removes "the need for country-by-country negotiations," while the cost is at "a level that is affordable for developed countries with the lowest purchasing power."
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