EU Panel May Start Accelerated Review of Merck’s Covid Pill
EU Panel May Start Accelerated Review of Merck’s Covid Pill
(Bloomberg) -- A European Union advisory committee will consider starting an accelerated review for Merck & Co.’s experimental antiviral pill against Covid-19 following the company’s announcement last week that it will seek emergency-use authorization from the U.S. Food and Drug Administration as soon as possible.
The panel will consider starting a “rolling review” in coming days, Marco Cavaleri, the head of biological health threats and vaccines strategy at the European Medicines Agency, said at a press briefing Tuesday. That’s a procedure where data is evaluated as it becomes available to speed up the process.
Merck’s new drug, molnupiravir, has led to optimism about the course of the pandemic after early studies show the drug has the potential to cut the rate of hospitalization and death by around 50% in mild to moderate Covid patients. The study results were so encouraging that Merck and partner Ridgeback Biotherapeutics LP elected to begin the process of obtaining regulatory clearance early. It’s also a glimmer of hope for the developing world, where vaccinations have been lagging.
Separately, the EMA said it will try to align the use of boosters as much as possible among member states, after it endorsed extra shots of Pfizer Inc.’s Covid-19 vaccine for all adults, as well as extra doses of Moderna Inc.’s for those with severely weakened immune systems.
“At least 10 member states have decided to give booster doses,” Cavaleri said. “At this point in time it’s challenging to enter into a granular discussion about which population should receive a booster or not. Normally this type of decision is taken at a national or even local level. What we can say now is the benefit-risk of the booster is positive.”
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