Gilead Sciences, Inc. (Nasdaq: GILD) announced that the United Arab Emirates’ Ministry of Health and Prevention has granted regulatory approval of Veklury® (remdesivir) as an Emergency Medicine for treatment of SARS-CoV-2 infection, the virus that causes COVID-19.
The regulatory approval is supported by clinical data from the U.S. National Institute of Allergy &Infectious Diseases’global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and Remdesivir Compassionate Use Data, demonstrating the benefit of this treatment in helping patients recover faster, while having a trend towards a mortality benefit.
Gilead understands the urgent needs of patients around the world, and the company has proactively scaled up manufacturing of remdesivir to increase available supply, as rapidly as possible. While there is currently limited global supply of remdesivir, the company anticipates new supply of the drug to start to become available in July, with supply continuing to increase through the end of this year and into next year. Gilead will work closely with the health authorities in UAE to provide guidance on anticipated drug supply based on local incidence and severity of disease.