The Hague (AFP) – The European Medicines Agency said Tuesday 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 said 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 authorisation 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 hospitalisation and death in high-risk patients.
The watchdog said Tuesday it was 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 Merck pill should not be used by pregnant women or women who are not using contraception and could get pregnant, the EMA said.
“If EMA concludes that the benefits of Lagevrio outweigh its risks in treating Covid-19, it will recommend granting a marketing authorisation” by the European Commission, the body added.
Merck’s pill decreases the ability of the coronavirus to multiply by increasing the number of mutations in its genetic material (or RNA).
The Pfizer pill uses a different method, belonging to a class of antivirals called “protease inhibitors”, which block the action of an enzyme that is critical to viral replication.