Gilead seeks full approval for remdesivir from US FDA for COVID-19 treatment

Gilead Sciences has filed an application with the US Food and Drug Administration (US FDA) seeking full approval for remdesivir, its experimental COVID-19 drug currently used under emergency authorisation.

The antiviral drug was granted emergency use authorisation (EUA) in May by the US FDA.

The authorisation cleared the way for broader use of the drug in more hospitals around the US. But the EUA status is designed to be temporary.

Gilead said its marketing application for remdesivir, to be sold under brand name Veklury, is supported by data from two late-stage trials conducted by the drugmaker and another by the National Institute of Allergy and Infectious Diseases.

Remdesivir has already been approved by multiple regulatory authorities around the world, including in the European Union, Australia and Japan.

The US government has secured nearly all of remdesivir’s supply through September. To boost the drug’s availability globally, Gilead has signed multiple manufacturing and supply deals, including with Pfizer and Britain’s Hikma Pharmaceuticals.

A bipartisan group of state attorneys general urged the US government last week to allow other companies to make remdesivir to increase its availability and lower prices.