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Gilead's Veklury gets approval for COVID-19 treatment in Singapore

11 June 2020 | News

The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial and Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19.

Image Credit: shutterstock.com

Image Credit: shutterstock.com

Gilead Sciences, Inc. has announced that the Health Sciences Authority of Singapore (HSA) has granted conditional approval of Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19.

The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial and Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19. Singapore participated in both clinical trials and has enrolled around 100 patients. As part of the condition of the approval, data from on-going clinical studies will be submitted to HSA to ensure continued safety and efficacy of the product.

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 Singapore to provide guidance on anticipated drug supply based on local incidence and severity of disease.

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