FDA clears Merck’s pill for treating COVID-19
Molnupiravir only OK’d for high-risk adults with virus
The Food and Drug Administration on Thursday authorized a second antiviral pill for COVID19 but said it should not be preferred over other treatments.
The FDA cleared the pill, developed by Merck and known as molnupiravir, for adults who are vulnerable to becoming severely ill from COVID-19 and for whom alternative treatment options are “not accessible or clinically appropriate.”
The agency’s decision reflects concerns that Merck’s pill is only modestly effective and carries possible safety risks, including for pregnant women.
Merck’s treatment is expected to be available early next month.
With the omicron variant driving an onslaught of infections, the drug will be in greater supply in the coming weeks than other treatments in the United States.
Older people and those who have conditions such as obesity, diabetes or heart disease would be eligible to get a prescription for Merck’s pills if they become sick from the coronavirus and cannot get treatments like Pfizer’s newly authorized pills or monoclonal antibody drugs. Both vaccinated and unvaccinated people will be eligible.
But while the agency authorized Pfizer’s treatment for high-risk COVID19 patients as young as 12, it said that it was authorizing Merck’s drug only for adults because it “may affect bone and cartilage growth.”
Even before the FDA’s decision, some doctors and health officials had tempered expectations for Merck’s drug.
It appears far less effective than a similar pill from Pfizer, which received FDA authorization Wednesday and is expected to become more widely available in the United States starting in a few months.
In a key clinical trial, Merck’s drug reduced the risk of hospitalization or death by 30% when given to high-risk, unvaccinated people within five days of the onset of symptoms. Pfizer’s pill was found to reduce that risk by 88%.
“I don’t think Merck’s version is going to be the game-changer,” said Dr. Walid Gellad, who directs the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
Dr. Dean Li, a Merck executive, said Thursday that preliminary laboratory studies suggested that the drug was equally effective against omicron as it was against earlier versions of the virus. The company and independent researchers have been running experiments on how well the drug can stop the omicron variant from replicating.
The pills from Merck and Pfizer can be taken at home and are expected to reach many more people globally than monoclonal antibody treatments, which are typically given via intravenous infusions by a health care provider.
Merck’s treatment is meant to be taken as 40 pills over five days. The company is ready to ship the first 378,000 courses for the United States within days. Merck is expected to fulfill the federal government’s full order of enough pills for 3.1 million people, at a cost of about $700 a person, by the end of January.
Pfizer is expected to provide enough of its pills, known as Paxlovid, for 265,000 Americans before the end of January.
The federal government on Thursday allocated the first 65,000 treatment courses to states and said the first shipments would begin arriving within the next few days.
As was done with COVID19 vaccines, the federal government will allocate the pills to states, which can then distribute them to health departments and pharmacies. The government will also ship the pills directly to community health centers.
To get Merck’s pills, the FDA said, patients must test positive for the virus and get a prescription from a health care provider, no more than five days after symptoms emerge.
Merck’s pill works by introducing errors into the virus’s genes to stop it from replicating, which has raised concerns about the risk that it could cause reproductive harm. The risk is hypothetical, and Merck says it has not been borne out in its studies.
The FDA said that women who were pregnant should generally not take the pills, but that there could be exceptions. The agency said that women who may become pregnant should use contraception while taking the pills and for at least four days after. The male partners of women who could become pregnant should use contraception while taking the pills and for at least three months after, the agency said.
Some scientists have also raised concerns that the pills could in theory cause the virus to mutate in a way that does not stop it from replicating but instead leads to the emergence of a new variant.