Gilead shares fell 1.5% late in the afternoon.
Gilead Sciences Inc has filed an application with the United States Food and Drug Administration for full approval of remdesivir, its investigational COVID-19 drug currently in use under emergency authorization, the drugmaker said on Monday.
The antiviral drug, which helped shorten recovery time in hospital in a US trial, has been at the forefront of the battle against the pandemic after the FDA granted it authorization for use emergency (EUA) in May.
The authorization paved the way for wider use of the drug in more hospitals in the United States, which have recorded more than 162,600 COVID-19 deaths and more than 5 million infections. But EUA status is designed to be temporary.
Gilead said its marketing claim for remdesivir, which will be sold under the brand name Veklury, is supported by data from two late stage trials conducted by the drugmaker and one by the National Allergy Institute and infectious diseases.
Remdesivir has already been approved by several regulatory authorities around the world, including in the European Union, Australia and Japan.
The US government has assured almost the entire supply of remdesivir until September. To increase the availability of the drug around the world, Gilead has signed several manufacturing and supply agreements, 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 manufacture remdesivir to increase its availability and lower prices.
Gilead shares fell 1.5% late in the afternoon.
Oppenheimer analyst Hartaj Singh said investors feared that if Gilead could not get full approval at least before the end of the year, he might not be able to meet sales estimates for 2020 for the drug.
“On many occasions, government entities are expressly prohibited from purchasing or using drugs not approved by the FDA and other regulatory authorities.
Consensus sales expectations for remdesivir reach $ 2.2 billion for the year, Singh said, after Gilead raised its full-year sales target last month to include revenue from the drug.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
