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Tuesday, November 23, 2021
EU watchdog could approve Merck Covid pill ‘within weeks’
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The European Medicines Agency (EMA) says it may decide “within weeks” whether to approve Merck’s anti-Covid pill, Lagevrio, which could offer patients an easy at-home treatment for the disease.
“EMA will assess the benefits and risks of Lagevrio under a reduced timeline and could issue an opinion within weeks if the data submitted are sufficiently robust and complete,” the body says in a statement.
On Friday, the EMA had issued advice allowing individual EU countries to decide for themselves on using Lagevrio — also known as molnupiravir — in emergency situations, “in light of rising rates of infection and deaths” from COVID-19.
It is also weighing a similar authorization for a pill from Pfizer.
The two drugs from the US pharma giants represent a potentially groundbreaking step in the fight against coronavirus, as studies show they cut the risk of hospitalization and death in high-risk patients.
The watchdog says it is able to move so quickly as it “has already reviewed a substantial portion of the data on the medicine during a rolling review,“ including from laboratory and animal studies, production data and “data on efficacy and safety.”
EMA’s human medicines committee also “assessed data from completed and ongoing clinical studies.”
The Times of Israel Community.