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A special Food and Drug Administration panel has narrowly authorized Merck's molnupiravir COVID-19 treatment for immunocompromised adults with mild-to-moderate symptoms.
The new drug will be the first COVID-19 treatment that can be taken from home in capsule form. The FDA's panel voted 13-10 to approve the drug and determined that the benefits of the drug outweighed the risks. Such risks include potential birth defects in pregnant women.
Furthermore, the panel specified one key demographic that Merck's pill should be given to. The panel recommended that the molnupiravir pill be used for immunocompromised adults, including people who have conditions such as asthma and obesity.
The FDA tested the drug against rats and found a less-than-satisfactory conclusion. Scientists affiliated with the FDA claim that birth defects were found in the skeleton, eyes and kidneys of newborn rats, raising the question of whether or not pregnant women would be safe taking the pill. Merck has already begun putting advisories in its presentations discouraging such women from consuming molnupiravir.
Merck's pill is significant for many reasons, most prominently its approach to fighting off COVID-19. According to The Associated Press, the pill is expected to insert "tiny errors into the coronavirus' genetic code to stop it from reproducing." Merck scientists say that the pill has already been tested against COVID-19 variants, including delta. However, the company hasn't tested the drug against those who have already been vaccinated.
Merck has not commented on the FDA panel's decision.
For more reporting from the Associated Press, see below:
The panel's recommendations aren't binding but often guide FDA decisions.
The meeting comes as U.S. infections are rising again and health authorities worldwide size up the threat posed by the new omicron variant.
If authorized, Merck's pill would be the first that doctors could prescribe for patients to take on their own to ease symptoms and speed recovery, a major step toward reducing hospital caseloads and deaths. The drug, molnupiravir, is already authorized for emergency use in the U.K.
Given the ongoing threat, the FDA is widely expected to approve emergency use of Merck's pill. But new data released last week painted a less compelling picture than when the company first publicized its early results in October.
Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30 percent among adults infected with the coronavirus when compared with adults taking a placebo. That effect was significantly less than the 50 percent reduction it first announced based on incomplete results.
FDA scientists said Tuesday the reasons for the difference were unclear but appeared to be due to higher-than-expected hospitalizations among patients taking the drug during the second half of the study.
Merck scientists said they believe their drug will be effective against the new omicron variant.
Data from a handful of patients with prior infections suggested the drug had little benefit. Still, it may be impractical for doctors to screen out those patients. The Merck drug works best when given within five days of first COVID-19 symptoms, underscoring the need for speedy treatment.
Merck tested the drug in adults with mild-to-moderate COVID-19 who were considered higher risk due to health problems like obesity, diabetes or heart disease. That's the same group that currently receives antibody drugs, which help the immune system fight the virus. The FDA has authorized three antibody drugs for COVID-19 but all have to be given by IV or injection at hospitals or clinics.
Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug from Pfizer is close behind and is also under review.
Pfizer's drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck's pill and haven't been linked to the kind of mutation concerns raised with Merck's drug.
Pfizer said this week that its drug shouldn't be affected by the omicron variant's mutations.
Updated 11/30/2021 at 5: p.m. ET: This story has been updated with additional information.
