Merck’s Covid-19 pill set for review by FDA advisory panel
The Peninsula
The U.S. Food and Drug Administration will send Merck & Co.’s Covid-19 pill to an advisory committee for review, using a public forum to discuss any safety concerns ahead of a potential authorization, according to two people familiar with the plans.
The FDA announcement is expected imminently, and means the agency opted not to skip the advisory committee step, which it occasionally does when it’s racing to get a drug to market quickly. Safety concerns have been raised by some experts, and the committee will weigh in before the FDA makes a decision, the person said.
Merck and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir earlier this week, a step toward clearance for a pill meant to treat Covid-19 in high-risk adults.