Final US hurdle for Merck's COVID-19 pill: FDA panel review

WASHINGTON (AP) — An experimental COVID-19 drug that could soon become the first U.S.-authorized pill to treat the coronavirus faces one final hurdle Tuesday: A panel of government experts will scrutinize data on the medication from drugmaker Merck.

The Food and Drug Administration is asking its outside experts whether the agency should authorize the pill, weighing new information that it is less effective than first reported and may cause birth defects. The panel’s recommendations aren't binding but often guide FDA decisions.

Tuesday’s meeting comes as U.S. infections are rising again and health authorities worldwide scramble to size up the threat posed by the new omicron variant.

If authorized, Merck’s pill would be the first that U.S. patients could take at home to ease symptoms and speed recovery, a major step toward reducing hospital case loads and deaths. The drug, molnupiravir, is already authorized for emergency use in the U.K.

Given the ongoing threat of the pandemic the FDA is widely expected to approve emergency use of Merck’s pill. But new data released last week paint a less compelling picture of the drug than when the Merck first publicized its early results in October.

On Friday, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, significantly lower than the 50% reduction it first announced based on incomplete results.

FDA regulators said they were still reviewing Merck’s update and would present a new assessment of the drug’s benefits to the outside panel. Molnupiravir’s effectiveness is a key question as panel members weigh whether to recommend the drug and for whom.

One key question is whether the drug should be restricted from use in pregnant women or women of...