The US Food and Drug Administration (FDA) has approved the use of the experimental drug, remdesivir, to treat hospitalised COVID-19 patients. FDA Commissioner Stephen Hahn made the announcement on 1st May 2020.
“This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with Covid-19 and is the first authorized therapy for Covid-19,” Hahn said.
The FDA had issued an emergency-use authorization stating that the benefits of Remdesivir outweigh its risks in patients. An emergency-use authorization is just short of the full FDA approval for the treatment of the virus.
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Denise Hinton, the FDA’s chief scientist, on the authorization letter, said there is “no adequate, approved, and available alternative to the emergency use of remdesivir for the treatment of COVID-19.”
Gilead Sciences had said that remdesivir had helped improve outcomes for patients with Covid-19. Remdesivir is given via intravenous infusion and data suggests that it works better when given earlier in the course of infection.
Promising Situation
President Donald Trump had said the drug presents a “very promising situation”.
“An important treatment for hospitalized corona patients and something I spoke with Dr. Hahn and Dr. (Andrew) Fauci. I spoke with Deborah (Birx) about it. It is really a very promising situation,” Trump said.
Nigerian doctor, Babafemi Taiwo of Gilead Sciences had led a part of a major study on how the antiviral drug is appearing to treat the virus. CNN had interviewed the doctor to discuss, from preliminary results, how the drug can help hospitalised patients make quick recoveries.
Gilead Sciences also says it has donated its existing supply of the drug to COVID-19 patients. It says the supply can cover at least 140,000 treatment courses for the patients.
“The company has set a goal of producing at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required,” Gilead Sciences said in a statement.
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