WASHINGTON: In an official letter on Friday, the United States Food and Drug Administration (FDA) said that the experimental drug remdesivir which is antiviral has been approved under emergency to treat hospitalized patients with severe Covid-19.
The FDA said in a statement that Gilead Science’s intravenous drug would be specifically indicated for hospitalized coronavirus patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.
Speaking to the media, FDA Commissioner Stephen Hahn said that Remdesivir is the first authorized therapy drug for Covid-19 in the United States.
"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 issued an emergency-use authorization on Friday which is a lower regulatory bar than full FDA approval.
Speaking about this emergency approval of drug, US President Donald Trump called remdesivir a "very promising situation."
The FDA also said that the distribution of the drug would be controlled in order to consistently use the drug with the "terms and conditions" of the authorization.
Gilead, the company which makes remdesiver, has donated the existing supply of the drug, which could cover at least 140,000 treatment courses for patients with Covid-19.
"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," the company said in a statement on Friday.
The company also recommended that patients on ventilators take the drug for 10 days and non-ventilator patients only five days.
There are also possible side effects of remdesivir which include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver and infusion-related reactions like low blood pressure, nausea, vomiting, sweating and shivering.