Gilead applies for FDA approval to treat coronavirus patients with remdesivir
pharmafile | August 11, 2020 | News story | Manufacturing and Production | COVID-19, Gilead, coronavirus
Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients.
The drug would go under the brand name of Veklury. The treatment is already available on an emergency basis for people suffering with severe symptoms from coronavirus. It has not received general approval to treat the virus in the US, but has in several European countries and Japan.
The request for approval comes nearly two months after a study from the National Institute of Allergy and Infectious Diseases which showed positive results, with the drug effectively blocking the virus from replicating. An earlier trial across Europe and the US also showed a reduced recovery time for coronavirus patients in a third of 1,000 surveyed.
Merdad Parsey, Gilead’s Chief Medical Officer, said: “Today’s filing is an important milestone as we continue to partner with the U.S. government and health care authorities around the globe to address the treatment needs of patients with COVID-19.
“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.”
Due to the US government buying up all of the supply of remdesivir, the company have signed deals with Pfizer and Hikma to make the drug available around the world. Recently, a bipartisan group of US Senators has asked the government to allow other companies to make remdesivir in the US to increase its availability and lower its price through competition.
Conor Kavanagh
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