Meeting as US infections rise
Government health advisors on Tuesday weighed the benefits and risks of Merck’s closely-watched drug, which could soon become the first US-authorized pill for patients to take at home to treat COVID-19.
The Food and Drug Administration asked its outside experts whether the agency should authorize the pill, weighing in on new information that it is less effective than previously reported and can cause birth defects. Voting was likely to take place on Tuesday afternoon. Panel recommendations are not binding, but often guide FDA decisions.
The meeting comes as US infections continue to rise again and health officials around the world shape the threat posed by the new Omicron variant.
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If authorized, Merck’s pill would be the first that doctors can prescribe to patients to reduce symptoms and speed up recovery, a major step toward reducing hospital caseloads and deaths. The drug, molnupiravir, is Already authorized for emergency use in the UK
In view of the ongoing threat, FDA widely expected to approve emergency use of Merck’s pill, But new data released last week paints a less compelling picture than it first publicized its initial results in October.
Last week, Merck said final study results showed that molanupiravir reduced hospitalization and death in adults infected with the coronavirus by 30%, when compared to adults taking a placebo. This effect was much less than a 50% reduction. first announced on the basis of incomplete results.
FDA scientists said Tuesday that the reasons for the difference were unclear, but appear to be due to higher hospitalizations than expected in patients who took the drug during the second part of the study. The effectiveness of molanupiravir is an important consideration as panel members weigh whether to recommend the drug and for whom.
Another question is whether pregnant women or women of child-bearing age should avoid the drug.
FDA scientists said Tuesday that the company’s studies in rats showed the drug caused toxicity and birth defects in the skeleton, eyes and kidneys. Taken together, FDA staff concluded the data “suggest that mollupiravir may cause fetal harm when administered to pregnant individuals.”
Regulators said they are considering prohibiting or cautioning against the use of mollupiravir during pregnancy but are leaving it as an option in rare cases. The FDA also proposed that doctors verify that patients are not pregnant before starting treatment and recommend contraceptives to some patients.
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In its presentations on Tuesday, Merck said it is not recommending the drug’s use in women who are pregnant or breastfeeding. But the drugmaker opposed a blanket ban on prescribing them to patients, arguing that there may be some cases where the drug’s benefits outweigh its risks.
The drug uses a novel approach to fight COVID-19: it inserts tiny errors into the genetic code of the coronavirus to prevent it from reproducing. That genetic influence has raised concerns that the drug may induce more virulent strains of the virus. But FDA regulators said Tuesday that the risk is theoretical and unlikely.
Merck scientists said they believe their drug will be effective against the newer version of Omicron. He said the drug works against other types, including the prevalent delta strain.
Panelists are also weighing whether the tablets should be given to patients who have been vaccinated or who have previously had COVID-19. Merck did not study the drug in vaccinated people, but data from a handful of patients with prior infections suggested it had little benefit. Still, it may be impractical for doctors to examine those patients. Merck the drug works best when given within five days of the first COVID-19 symptoms, underscoring the need for prompt treatment.
Merck tested the drug in adults with mild to moderate COVID-19 who were considered to be at high risk because of health problems such as obesity, diabetes or heart disease. This is the same group that currently receives antibody drugs, which help the immune system fight off the virus. The FDA has authorized three antibody drugs for COVID-19, but all must be given by IV or injection in hospitals or clinics.
Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug from Pfizer is behind and is also being reviewed.
Pfizer’s drug is part of a decades-old family of antiviral pills, known as protease inhibitors, which are a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and have not been associated with mutagenicity concerns raised with Merck’s drug.
Pfizer said this week that its drug should not be affected by mutations in the Omicron variant.