FDA panel endorses Merck’s COVID-19 pill, molnupiravir

A U.S. Food and Drug Administration advisory committee on Tuesday narrowly endorsed a COVID-19 pill developed by Merck and shown to reduce hospitalization rates for those with mild to moderate symptoms of COVID-19, determining that the known and possible benefits outweigh the risks.

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Update 5:25 p.m. EST Nov. 30: Committee members who voted against endorsing molnupiravir pointed to the risk that Merck’s anviral pill could create new variants of COVID-19, among other concerns.

“As an outpatient therapy, there’s really no effective way to control the manner in which the patient is taking the medication and (they) may potentially transmit (the virus) to family or their close contacts while taking the medication or soon afterwards,” Dr. Peter Weina, director of the Defense Health Agency, said while explaining why he voted not to endorse the drug.

Weina added that he was not convinced that the benefits outweighed the risks, pointing to evidence that the drug decreased the absolute risk posed by COVID-19 by only 3%.

Last week, officials with Merck reported final study results which showed that molnupiravir reduced the risk of hospitalization and death among people who took the pill when compared to those taking a placebo by 30%. Previously, the company had announced that early results from the same study showed a 50% reduction in hospitalizations or deaths.

The reasons for the differences between the early and final study results remained unclear Tuesday.

Los Angeles-based Dr. W. David Hardy voted in favor of endorsing molnupiravir, although he and several other panel members emphasized that warnings should be put in place to inform pregnant people of the possible risks posed by using the drug. Animal studies showed that molnupiravir negatively affected the development of bones in fetuses.

“COVID-19 is still a emergency situation,” Hardy said while explaining his vote. “As a front-line clinician and treating patients, both inpatients and outpatients, there is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderate symptomatic persons would be available.”

Update 4:58 p.m. EST Nov. 30: The FDA’s Antimicrobial Drugs Advisory Committee voted Tuesday to endorse making Merck’s antiviral pill, molnupiravir, available by prescription to people with mild or moderate symptoms of COVID-19 who are also at high risk of severe infection.

If the FDA grants emergency use authorization for the drug, it will only be available to people with symptomatic COVID-19 infections and it would not be available over the counter.

Panel members raised concerns over the drug’s potential impact on people who are of childbearing age, as animal studies showed molnupiravir had the potential to negatively impact bone development in fetuses. They also questioned the possibility that the drug could drive mutations of the virus.

Earlier this month, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency authorized molnupiravir for treatment of people with mild to moderate COVID-19 who have at least one risk factor for developing severe illness. Agency officials pointed to clinical data which showed the drug, which interferes with the replication of the virus, was “safe and effective at reducing the risk of (hospitalization) and death.”

>> Related: Coronavirus: United Kingdom authorizes Merck’s COVID-19 pill

Update 4:54 p.m. EST Nov. 30: In a 13-10 vote, the FDA’s Antimicrobial Drugs Advisory Committee endorsed Merck’s antiviral pill, molnupiravir, for treatment of mild to moderate COVID-19 in people who are at high risk of getting severe infections.

Officials said that the pill showed its greatest benefit for patients who began treatment within five days of experiencing symptoms of COVID-19. In a trial involving participants from Latin America, Europe, Africa, North America and Asia, COVID-19 patients received 800 mg of molnupiravir or a placebo every 12 hours for five days.

“Molnupirivir has been shown to reduce the risk of hospitalizations and deaths among adults with mild to moderate COVID-19 and who are at high risk for progression to severe COVID-19,” Dr. Aimee Hodowanec, senior medical officer for the Division of Antivirals, said during an FDA presentation examining the available data. “Molnupirivir appeared generally safe in adults with mild to moderate COVID-19.”

An official for Merck said the company expects the pill to be effective against the newly identified omicron variant based on evidence of its effectiveness against other variants of concern, such as delta, mu and lambda. However, the official noted that the company has yet to complete testing specifically aimed at the omicron variant.

Health officials have warned that mutations seen in the omicron variant could indicate that it is more transmissible than currently dominant viral variants; however, more research is needed.

Original report: An advisory committee for the U.S. Food and Drug Administration will meet Tuesday to consider recommending approval of a pill that has been shown to cut hospitalization rates for those with the COVID-19 virus.

The FDA’s Antimicrobial Drugs Advisory Committee will take up the question of whether the antiviral pill molnupiravir, made by pharmaceutical company Merck, should be approved for use in the United States.

Molnupiravir is the first of two antiviral pills the agency will be considering for use in the U.S. Pfizer’s Paxlovid will be reviewed by the committee likely next week.

Both drugs have a five-day treatment course. Molnupiravir must be started within five days of symptom onset.

If the drugs are approved for use, people with a moderate case of COVID-19 will be able to take the pills at home instead of having to go to a health care facility for treatment.

As of Tuesday, the only FDA-authorized treatments for COVID-19 patients who are not hospitalized are monoclonal antibodies. Generally, monoclonal antibodies require intravenous infusion in a health care setting.

“This [could be] huge for the world, in terms of what we can do to slow down, and hopefully stop, the transmission of this virus,” Dr. Phyllis Tien, an infectious disease specialist at the University of California, San Francisco, and a member of the COVID-19 Treatment Guidelines panel for the National Institutes of Health, told NPR.

According to Merck’s data analysis, molnupiravir cuts the risk of hospitalization and death in COVID-19 patients by 30%, compared to monoclonal antibodies, which have been shown to reduce this risk in severe COVID-19 patients by 70% to 85%.

Merck’s research at first showed molnupiravir cut hospitalizations with severe COVID-19 and deaths from the virus by 50%. However, last week the company released results from a larger sample showing a 30% reduction.

According to Merck, the drug works by inserting mutations into the coronavirus’ genetic code, eventually making it unable to reproduce itself.

According to the FDA’s staff report to the committee, that agency has questions about what side effects such a change in the genetic code could cause, such as birth defects. Merck noted that the drug has not been tested in pregnant women.