⁍ Gilead Sciences Inc has filed an application with the U.S. Food and Drug Administration seeking full approval for remdesivir.


⁍ The experimental drug is currently used under emergency authorization.


⁍ Remdesivir has already been approved by multiple regulatory authorities around the world.


– If the FDA gives its blessing, hospitals in the US will soon be able to get their hands on an antiviral drug used to fight the deadly West Nile virus. Gilead Sciences on Monday announced that it has filed a marketing application with the FDA for remdesivir, which was granted emergency use authorization by the agency in May, reports Reuters. The authorization allows the drug to be sold in the US under the brand name Veklury. The drug 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 Inc and Britain’s Hikma Pharmaceuticals Plc. 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. Shares of Gilead were down 1.5% in late afternoon trading. Oppenheimer analyst Hartaj Singh said investors are worried that if Gilead cannot secure full approval until at least by the end of the year, it might not be able to meet 2020 sales estimates for the drug. ‘On many occasions, government entities are expressly forbidden from buying or utilizing drugs not approved by the FDA and other regulatory authorities,’ Singh said, after Gilead raised its full-year sales target last month to include revenue from the drug.



Source: https://www.reuters.com/article/us-health-coronavirus-gilead-sciences-re/gilead-seeks-us-approval-for-covid-19-treatment-remdesivir-idUSKCN2561WY