FDA Approves Remdesivir For Covid-19 Treatment

The Food and Drug Administration on Thursday approved remdesivir as a treatment for hospitalized coronavirus patients, Gilead Sciences said, making it the first FDA-approved drug for Covid-19.

Key Facts

The drug was previously granted an emergency use authorization in May, which allowed healthcare providers to administer the treatment even though it wasn’t formally approved by the FDA.

Remdesivir, which is sold under the brand name Veklury, “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” Gilead said.

The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.

Clinical trial data has been mixed: A randomized trial from the National Institute of Allergy and Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed, found last week the drug did not increase the chances of survival or result in faster recovery.

Gilead shares jumped 3.8% in after hours trading following the announcement. 

Crucial Quote

“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Gilead CEO Daniel O’Day in a statement.

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Key Background

President Donald Trump took remdesivir when being treated for the coronavirus earlier this month. Follow me on Twitter. Send me a secure tipRachel SandlerI’m a San Francisco-based reporter covering breaking news at Forbes. I’ve previously reported for USA Today, Business Insider, The San Francisco Business Times and San Jose Inside. I studied journalism at Syracuse University’s S.I. Newhouse School of Public Communications and was an editor at The Daily Orange, the university’s independent student newspaper. Follow me on Twitter @rachsandl or shoot me an email rsandler@forbes.com.

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Remdesivir is a prodrug of an adenosine triphosphate (ATP) analog, with potential antiviral activity against a variety of RNA viruses. Upon administration, remdesivir, being a prodrug, is metabolized into its active form GS-441524. As an ATP analog, GS-441524 competes with ATP for incorporation into RNA and inhibits the action of viral RNA-dependent RNA polymerase. This results in the termination of RNA transcription and decreases viral RNA production.

Remdesivir has an FDA Emergency Use Authorization for use in adults and children with suspected or confirmed COVID-19 in hospital with an SpO2 ≤94%.[L13239] This is not the same as an FDA approval.[L12609] The FDA Emergency Use Authorization suggests a loading dose of 200mg once daily in patients ≥ 40 kg or 5 mg/kg once daily in patients 3.5 kg to less than 40 kg, followed by a maintenance dose of 100mg once daily in patients ≥ 40 kg or 2.5 mg/kg once daily in patients 3.5 kg to less than 40 kg.[L13239] Patients not needing invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) should be treated for 5 days (including the loading dose on day 1), up to 10 days if they do not show improvement.[L13239] Patients requiring invasive mechanical ventilation or ECMO should be treated for 10 days.[L13239]

Clinical trials used a regimen of 200mg once daily on the first day, followed by 100mg once daily for another 9 days.[A191931,L12174,L12177] Early data suggests that some patients may benefit from only 5 days of treatment.[A198810] Remdesivir was originally investigated as a treatment for Ebola virus, but has potential to treat a variety of RNA viruses.[A191379] Its activity against the coronavirus (CoV) family of viruses, such as SARS-CoV and MERS-CoV, was described in 2017,[A191382] and it is also being investigated as a potential treatment for SARS-CoV-2 infections.[A191427,A193254]

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CNBC Television 1M subscribers The FDA has approved Gilead’s Remdesivir as a Covid-19 treatment. Previously, the drug was approved only for emergency authorization. Gilead stock was up 4 percent after the news. Meg Tirrell joins ‘Closing Bell’ to discuss. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. The News with Shepard Smith is CNBC’s daily news podcast providing deep, non-partisan coverage and perspective on the day’s most important stories. Available to listen by 8:30pm ET / 5:30pm PT daily beginning September 30: https://www.cnbc.com/2020/09/29/the-n… Connect with CNBC News Online Get the latest news: http://www.cnbc.com/ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBChttps://www.cnbc.com/select/best-cred…#CNBC

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