For Manojna Maddipatla
Aug 10 (Reuters) – Gilead Sciences Inc said on Monday it has applied to the U.S. Food and Drug Administration (FDA) for final approval under emergency conditions of remdesivir, its drug currently used to combat the disease. COVID-19.
The antiviral, which has helped shorten recovery time in COVID-19 patients in trials in the United States, has been at the forefront in the fight against the pandemic after the FDA approved its use in May.
This authorization paved the way for a wider use of it in hospitals in the United States, which records more than 162,600 deaths from COVID-19 and more than 5 million infected. However, your authorization is temporary.
Remdesivir has already been approved by multiple regulators around the world, in places like the European Union, Australia and Japan.
Gilead shares fell 1.5% in afternoon trading. Hartaj Singh, an analyst at Oppenheimer, said investors are concerned that Gilead may not be able to get full approval as it could cause it to fail to meet sales estimates for the drug in 2020.
(Report by Manojna Maddipatla in Bengaluru. Edited in Spanish by Rodrigo Charme)