- The Washington Times - Friday, October 1, 2021

Merck on Friday said it will seek emergency approval of an antiviral pill to treat COVID-19 after it significantly cut the risk of bad outcomes in clinical trials.

The New Jersey-based drugmaker said the drug, molnupiravir, cut the risk of hospitalization or death in half in high-risk patients with mild to moderate illness.

If authorized for use, it would be a groundbreaking treatment. Pills are easy to take and can reach a wider audience than monoclonal antibodies, an effective treatment in high demand.

Merck said it stopped the trial early in consultation with the Food and Drug Administration because the results were positive.

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a health care facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, a Miami-based company that worked with Merck.

The pills’ efficacy was lower than monoclonal antibodies, but those drugs are expensive and often given intravenously, making them a labor-intensive effort for overtaxed hospitals.

SEE ALSO: Rising reports of ‘breakthrough infections’ fuel vaccine skeptics, scramble reopening plans

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” Merck CEO and President Roger M. Davis said.

Two other groups, Pfizer and Atea Pharmaceuticals-Roche, are working on pill-form treatments.

Merck said its interim analysis was based on a randomized trial of 775 patients. Each of the trial participants had at least one risk factor that made them more susceptible to a bad outcome from COVID-19.

If authorized, Merck said it can make 10 million courses of treatment by the end of 2021 and produce more in 2022. Earlier this year, the U.S. government pre-purchased 1.7 courses for use once the FDA green-lights the treatment.

The company said it will provide “timely access” to the rest of the world based under a tiered pricing system under guidance from the World Bank.

Dr. Anthony Fauci called Merck’s announcement “very good news.”

“The data are impressive, there was a 50% diminution … in the placebo group there were eight deaths and in the treatment group, there were no deaths. That’s also very important and very good news,” Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said during a White House COVID-19 briefing.

He said the FDA will look at the data and work on its own timeline in deciding whether to authorize the treatment for emergency use.
White House COVID-19 Coordinator Jeff Zients said the pill regimen would be an “additional tool in our toolbox” to prevent the worst outcomes from the virus.

“Vaccination remains far and away our best tool against COVID-19,” he said. “It can prevent you from getting COVID in the first place, and we want to prevent infections, not just wait to treat them once they happen.”

• Tom Howell Jr. can be reached at thowell@washingtontimes.com.

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