Merck to seek fed approval for COVID antiviral pill (updated)

Daniel J. Munoz//October 1, 2021

Merck to seek fed approval for COVID antiviral pill (updated)

Daniel J. Munoz//October 1, 2021

Kenilworth-based global drugmaker Merck said it will seek federal approval for a COVID-19 antiviral pill following “compelling results” in trials, the company announced Oct. 1.

The drug, known as molnupiravir, reduced the risk of hospital or death by roughly 50% for those with mild to moderate cases of COVID-19, Merck said. Molnupiravir is ingested orally and works by inhibiting the replication of the COVID-19 virus inside the human body.

Trials found that 7.3% of patients who used the drug were still hospitalized or died from the virus. Merck said it will submit its results to the U.S. Food and Drug Administration for emergency approval.

There were 775 participants in the trial, all unvaccinated and at higher risk for catching the virus. All of them were confirmed to have COVID-19, and were given either molnupiravir or a placebo within five days of showing symptoms.

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Merck said the most common risk factors included obesity, being above 60 years of age, diabetes and heart disease.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic,” reads a statement from Merck President and Chief Executive Officer Robert Davis. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”

Merck believes it will be able to produce 10 million pills by the end of the year, and entered a supply agreement with the U.S. government earlier this year for 1.7 million doses of molnupiravir, contingent upon FDA approval. Purchase agreements with other world governments are also being discussed.

Officials from Merck and Ridgeback Biotherapeutics, which collaborated on the study, said the pill is also effective against the highly contagious delta variant, which makes up most new COVID-19 cases in New Jersey and across the nation.

“With the virus continuing to circulate widely … antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” reads a statement from Ridgeback CEO Wendy Holman.

Taking a shot

Merck, along with New Jersey-based drugmakers Sanofi and Johnson & Johnson, had been developing COVID-19 vaccines, but only J&J has been successful. Of the 11.7 million shots administered since mid-December last year, 444,894 were from J&J.

In September, J&J announced that a second shot was showing high effectiveness taken two or six months after the first dose. However, only Pfizer has gotten approval from the FDA and Centers for Disease Control and Prevention for booster shots, which are taken six months after the second dose.

State and county health officials are rolling out a massive infrastructure to administer the added jab to 1.1 million seniors, high-risk residents with serious medical conditions, and frontline workers who work at jobs that place them at a higher risk of exposure to COVID-19.

Those include “health care workers, grocery store workers, public transit workers, education staff, including teachers and support staff, and daycare workers, first responders, including firefighters and police, transit workers, food and agricultural workers, and U.S. postal service workers,” New Jersey Health Commissioner Judith Persichilli said earlier this week.

The Gloucester County mega-site at Rowan College of South Jersey is being brought back online, with plans to reopen two more of the state mega-sites, Persichilli said.

Editor’s note: A previous version of this story indicated that a vaccination mega-site would open at Rowan University, that was incorrect; the Gloucester Country mega-site will be located at Rowan College of South Jersey.