Remdesivir Given Regulatory Fast-Track to Market

A vial of the investigational drug remdesivir is visually inspected in March at a Gilead manufacturing site. (Credit: Gilead Sciences)

WASHINGTON (CN) — The Food and Drug Administration has given emergency-use approval to the antiviral drug remdesivir, allowing the product to reach the market without the typically required data supporting its safety and success.

President Donald Trump made the announcement Friday in the Oval Office afternoon alongside Gilead CEO Daniel O’Day, who said his company would donate 1.5 million vials of the drug that has shown promise in the treatment Covid-19. 

In a statement, the FDA said it granted the approval after determining it was “reasonable to believe” the drug is beneficial for Covid-19 patients, and based on the lack of alternative treatments already on the market. With the emergency authorization, doctors can administer remdesivir to patients with “suspected or laboratory-confirmed Covid-19” who are hospitalized with a severe case of the disease, according to an FDA statement

“Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen Hahn said. 

O’Day said the approval is an important advancement in the fight against Covid-19, and that Gilead and other companies are continuing to work on possible treatments.

“I think this is the first step today, and it may be like with other viruses that we’ve seen, that with this base step, with an antiviral like remdesivir, that the way to actually even get better results is to add medicines on top of an antiviral,” O’Day said at the White House Friday.

In a statement, Gilead Sciences said the 1.5 million doses it will donate equate to 10-day treatment courses for roughly 140,000 people, and that the company has already started scaling up its production of the drug with the aim of producing 500,000 courses by October and 1 million by the end of the year.

Additional clinical trials are still ongoing to determine whether a five-day or 10-day treatment course is best, the company said, and the emergency authorization issued Friday recommends the longer course for patients with more severe symptoms.

Earlier this week, the company announced a federally run trial found Covid-19 patients who were treated with remdesivir recovered four days faster than patients who received a placebo. The study also “suggested” a slightly decreased mortality rate for people treated with the drug. 

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force, emphasized that the drug’s impact on mortality is not yet proven but that the results of the trial are positive and indicate it “will be the standard of care” going forward.

“What it has proven is a drug can block this virus,” Fauci said Wednesday.  

Remdesivir has previously been tested as a treatment on other coronaviruses like SARS and MERS, as well as on viruses including Ebola and Marburg. In an open letter on the findings of the study, O’Day said Gilead scientists started looking at whether the drug could be helpful for Covid-19 patients since January.

This story is developing…

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