FDA issues emergency-use authorization for remdesivir to treat hospitalized patients with severe Covid-19
The experimental drug remdesivir has been approved to treat hospitalized patients with severe Covid-19, the US Food and Drug Administration said in a letter on Friday.Posted — Updated
The FDA issued an emergency-use authorization on Friday, saying the benefits of the drug outweigh its risks in patients. An emergency-use authorization is a lower regulatory bar than full FDA approval.
Denise Hinton, the FDA's chief scientist, said in the latter that there is "no adequate, approved, and available alternative to the emergency use of remdesivir for the treatment of COVID-19."
The FDA limited its authorization of the drug to adults and children with suspected or laboratory-confirmed Covid-19 and severe disease, which includes low blood oxygen levels, the need for oxygen therapy or the need for a ventilator or other intensive breathing support.
Possible side effects of remdesivir 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, the FDA said.
The federal government is expected to control the distribution of the drug, the letter says, in order to consistently use the drug with the "terms and conditions" of the authorization.
The intravenous drug is expected to be administered in a hospital setting by a healthcare provider, the agency said.
Earlier this week, a government-funded study found that patients who took remdesivir recovered faster than patients who did not. The drug improved recovery time for coronavirus patients from 15 to 11 days. That's similar to the effect that the influenza drug Tamiflu has on flu. Tamiflu also doesn't cure patients quickly, but can reduce how long they are sick.
The maker of remdesivir, Gilead Sciences, said on Wednesday that the company's existing supply of the drug could cover at least 140,000 treatment courses for patients with Covid-19.
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