FDA panel narrowly favors COVID-19 pill from Merck

WASHINGTON (AP) – A panel of U.S. medical advisers on Tuesday narrowly supported the benefits of a closely watched COVID-19 pill from Merck, setting the stage for the drug’s approval. the first that Americans can use at home to treat the virus.

A panel of the Food and Drug Administration voted October 13 that the benefits of the drug outweigh its risks, including potential birth defects if used during pregnancy. pregnant.

The team’s recommendation comes after hours of debate over the drug’s modest benefits and potential safety issues. Experts in favor of the treatment emphasize that it should not be used by pregnant women and urge the FDA to recommend additional precautions, including pregnancy testing for women prior to use. medicine.

The group’s vote was particularly in favor of the drug for adults with mild to moderate COVID-19 illness, who face the greatest risks, including those with underlying medical conditions. such as obesity, asthma and old age.

The FDA is not bound by the panel’s recommendation and is expected to make its own decision before the end of the year.

FDA approval of the drug, molnupiravir, could be an important step in treating the virus. It will give doctors the first drug they can prescribe for self-administration, reducing the burden on hospitals and helping to limit deaths.

The pill has been authorized in the UK

The photo goes with the story
FILE – This undated file image produced by Merck & Co. offer shows that their new antiviral is molnupiravir. An experimental COVID-19 drug that could soon become the first drug authorized by the US to treat the coronavirus faced one final hurdle on Tuesday: A team of government experts will take a close look. two data on this drug from drug manufacturer Merck. (Merck & Co. via AP, File)

THIS IS A BREAKING NEWS UPDATE. The AP’s previous story follows.

WASHINGTON (AP) – Government medical advisers on Tuesday weighed the benefits and risks of a closely watched drug from Merck that could soon become the first to be authorized by the United States. for patients to use at home to treat COVID-19.

The Food and Drug Administration asked its outside experts whether the agency should authorize the pill, considering new information that it is less effective than first reported, and can cause birth defects. A vote was expected on Tuesday afternoon. Panel recommendations are not binding but often guide FDA decisions.

The meeting comes as infections in the US are on the rise again and health authorities worldwide are intensifying the threat posed by the new omicron variant.

If approved, Merck’s pill would be the first drug doctors could prescribe to patients to self-administer to ease symptoms and speed up recovery, an important step towards reducing symptoms. reduce morbidity and mortality in hospital. The drug, molnupiravir, has been authorized for emergency use in the UK

In light of the ongoing threat, the FDA is expected to approve the emergency use of Merck’s pill. But new data released last week paints a less compelling picture than it did when the company first made the results public in October.

Last week, Merck said final study results showed that molnupiravir reduced hospitalization and death rates by 30% in adults with coronavirus, when compared with adults taking a placebo. That effect is significantly less than the 50% reduction it first announced based on incomplete results.

FDA scientists on Tuesday said the reason for the difference was unclear, but appeared to be due to a higher-than-expected number of hospital admissions in the second half of the study. The effectiveness of Molnupiravir is a factor to consider as panel members consider whether and to whom to recommend the drug.

Another question is whether pregnant women or women of childbearing age should avoid the drug.

FDA scientists said on Tuesday that the company’s studies in mice showed the drug caused toxicity and birth defects in the skeleton, eyes and kidneys. Taken together, FDA officials concluded the data “suggests that molnupiravir may cause fetal harm when administered to a pregnant woman.”

Regulators say they are considering banning molnupiravir during pregnancy or warning against it but leaving it as an option in rare cases. The FDA also recommends that doctors verify patients are not pregnant before starting treatment and recommends contraceptives for some patients.

In its presentations Tuesday, Merck said it does not recommend the drug for women who are pregnant or breastfeeding. But the drug’s maker has objected to a restriction on prescribing to those patients, arguing that there may be certain circumstances where the benefits of the drug outweigh the risks.

The drug uses a new method to fight COVID-19: It inserts small errors into the coronavirus’ genetic code to prevent it from reproducing. That genetic effect has raised concerns that the drug could promote more virulent strains of the virus. But FDA regulators said Tuesday that the risk is theoretical and appears unlikely.

The Merck scientists say they believe their drug will be effective against the new omicron variant. They say the drug works against other variants, including the prevailing delta strain.

Panelists are also considering whether to give the drug to patients who have been immunized or previously received a shot of COVID-19. Merck has not studied the drug in vaccinated people, but data from some patients with prior infections suggests it has little benefit. However, it may not be practical for doctors to screen such patients. Merck works best when taken within five days of first COVID-19 symptoms, underscoring the need for prompt treatment.

Merck tested the drug in adults with mild to moderate COVID-19 who are considered at higher risk for health problems such as obesity, diabetes, or heart disease. It is the same group that is currently receiving antibody drugs, which help the immune system fight off the virus. The FDA has approved three antibody drugs for COVID-19 but all must be given intravenously or given in a hospital or clinic setting.

Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug to Pfizer is behind and is also being considered.

Pfizer’s drugs are part of a decades-old line of antiviral drugs called protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently from Merck’s drugs. and unrelated to the type of mutation posited with Merck’s drug.

Pfizer this week said its drug is not affected by mutations in the omicron variant.

The Associated Press Health and Science Division receives support from the Howard Hughes Health Institute’s Science Education Department. AP is solely responsible for all content.

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