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.”