Merck requests FDA authorization for its anti-COVID-19 pill, the next step towards rolling it out

Merck requests FDA authorization for its anti-COVID-19 pill, the next step towards rolling it out

  • Merck said Monday it had applied for FDA authorization for its COVID-19 antiviral drug.
  • If cleared, it would be the first oral antiviral in use for COVID-19. 
  • Early trial results suggested the pill reduces hospitalization by 50%, the company said. 

Merck is seeking authorization for its COVID-19 antiviral pill, the company said Monday in a joint statement with Ridgeback Biotherapeutics

The company submitted an application for emergency use authorization to the US Food and Drug Administration (FDA) and is “actively working” with regulatory agencies worldwide, per the statement. 

If authorized, the drug, called molnupiravir, would become the first oral antiviral treatment for COVID-19.

The drug, jointly developed by Merck and Ridgeback Biotherapeutics, “significantly reduced the risk of hospitalization or death,” the companies said in a statement on October 1.

The claim comes from a trial which tested the pills on 775 adults with mild to moderate COVID-19, Insider previously reported.

Of those, 14.1% who received a placebo were hospitalized or died, compared to 7.3% who received molnupiravir, the companies said. The results have not been published in a peer-reviewed journal. 

The drug is also being tested as post-exposure treatment, meaning it could be taken as a pill after someone believes they were exposed, but still in time to deal with symptoms.

Molnupiravir would have the advantage of being taken orally. Antiviral remdesivir and monoclonal antibody therapies are given intravenously, which means people need to be at the hospital or in a clinic, per Bloomberg.

The next generation of treatments for COVID-19 could come in the form of pills, nasal sprays, or inhalers, Insider’s Aria Bendix and Andrew Dunn previously reported.

Other companies are testing oral antiviral medicine for COVID-19. Pfizer and Roche are expecting trial results by the end of the year, Insider previously reported. 

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