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FDA panel endorses emergency use authorization for Merck COVID-19 pill

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FDA panel endorses emergency use authorization for Merck COVID-19 pill
Ken Frazier, chairman and chief executive officer of Merck & Co., speaks during an event in the Eisenhower Executive Office Building in Washington, DC on Wednesday, March 10, 2021. President Biden will double the U.S. order of Johnson & Johnson's one-shot vaccine, seeking another 100 million doses, bringing the country's total vaccine supply to enough for 500 million people. Photo by Al Drago/UPI | License Photo

Nov. 29 (UPI) -- A Food and Drug Administration advisory panel on Tuesday voted to endorse Merck's experimental COVID-19 pill.

The Antimicrobial Drugs Advisory Committee voted 13-10 to recommend emergency use authorization for Merck's molnupiravir oral capsules, the company announced.

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"With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed. That is why we are moving with speed and rigor to pursue authorizations and to accelerate broad global access to this investigational medicine," Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, said.

Merck submitted its request for the emergency use authorization for the drug, developed with Ridgeback Biotherapeutics, on Oct. 8. The FDA and Centers for Disease Control and Prevention must ultimately grant final authorization for it to become the first approved treatment to utilize a pill rather than an IV or injection.

RELATED Success of COVID-19 antiviral pills hinges on access to speedy, accurate tests

Vaccine maker Pfizer has also requested FDA authorization for experimental antiviral treatment, Paxlovid, ingested in a series of pills. The United States has agreed to buy 10 million treatment courses of Pfizer's drug.

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Briefing materials provided by Merck to the advisory committee included an 80-slide presentation from Dr. Sean Curtis, the senior vice president of global regulatory affairs and clinical safety at Merck.

Curtis' presentation notes "many Americans remain at risk" of suffering from the coronavirus because of "vaccine breakthrough infections."

RELATED U.S. agrees to buy 10 million courses of Pfizer COVID-19 pill Paxlovid

"There are no adequate, approved oral antiviral agents available for the treatment of patients with mild to moderate COVID-19," the presentation says.

Data released by Merck ahead of the meeting shows molnupiravir reduces the risk of hospitalization and death in COVID-19 patients by 30%. Those results are much lower than previous estimates from the company, which found that the drug reduced the risk of hospitalization and death by 50%.

Pfizer has said that its Paxlovid can reduce the risk of hospitalization and death by 89%.

RELATED Pfizer to allow generic COVID-19 pill production for low-income countries

Merck has said that reactions to the pill series, which is taken over five days, have been "generally well tolerated."

A study published in the Journal of Infectious Disease in August found that molnupiravir was effective in reducing COVID-19 in mice but that a byproduct of the drug led to some mutations that could lead to cancer.

"There are risks for the host in that the same mutagenic activity that impacts viral replication has the potential for incorporation and mutagenesis of host DNA," that study reads.

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Scientists with the FDA noted in documents prepared for the Tuesday meeting that studies on molnupiravir conducted in rats and rabbits shows that the drug could have risks of side effects in pregnant women, including harm to bone formation of the fetus causing "skeletal malformations."

"Based on these findings, molnupiravir is not recommended for use during pregnancy," the presentation from Merck notes.

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