Kenilworth-based Merck is asking the U.S. Food and Drug Administration for emergency approval of a COVID-19 antiviral pill after trials for the drug showed promising results, the company announced Oct. 11.
The bid from Merck and Ridgeback Biotherapeutics for approval of molnupiravir comes 10 days after the global drugmaker touted “compelling results” in its trials, and announced plans to go to the FDA for approval.
Merck said in its statement that molnupiravir was found in trials to reduce the risk of hospital or death by roughly 50% for those with mild to moderate cases of COVID-19. Trials found that 7.3% of patients who used the drug were still hospitalized or died from the virus, compared to 14.1% of patients who took the placebo.
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.
Molnupiravir is ingested orally and works by inhibiting the replication of the COVID-19 virus inside the human body.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” reads an Oct. 10 statement from Robert Davis, Merck’s chief executive officer.
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.
White House Chief Medical Advisor Dr. Anthony Fauci at Jan. 21, 2021 press briefing – OFFICIAL WHITE HOUSE PHOTO BY CHANDLER WEST
Last week at a White House COVID-19 press briefing, Dr. Anthony Fauci, the White House chief medical advisor and head of the National Institute of Allergy and Infectious Disease, said the trial results were “very encouraging,” but stressed the need for a thorough FDA review.
“It is very important that this now must go through the usual process of careful examination of the data by the [FDA] both for effectiveness, but also for safety because whenever you introduce a new compound, safety is very important,” he said.
Vaccines, he added, would still be a vital tool against the virus, rather than treating it.
In New Jersey, nearly 6 million people who live, work or study in the state have gotten the vaccine, though inoculation rates across the nation have been moving at a snail’s pace since the summer.
Amid delta variant surges, state efforts are shifting to administering the Pfizer booster shot, taken six months after the second dose, to roughly 1.1 million high-risk patients, elderly residents and front-line workers.
While the surge of the delta variant has shown signs of tapering off, state health officials said they’re still worried about COVID-19 holiday spikes beginning after Thanksgiving.
Editor’s note: This story was updated at 9:33 a.m. EST on Oct. 12, 2021, to include Ridgeback Biotherapeutics, which collaborated on the development of the antiviral treatment with Merck. Miami, Fla.-based Ridgeback is a biotechnology company focused on emerging infectious diseases.
