Merck battles to get green light from European regulator for Covid-19 pill
Merck, the drugmaker behind one of the world’s first Covid-19 antiviral pills, is reportedly unlikely to get marketing authorisation from the European Medicines Agency.
It is “possible” that the oral drug molnupiravir will not get the green light from the European regulator at all, the Financial Times first reported, citing people familiar with the matter.
The landmark drug, dubbed a ‘game changer’ in tackling the virus, has been approved by the US Food and Drug Administration for restricted us.
The UK has bought 2.23m courses of the drug and is deploying it in clinical trials before upgrading it to a first, or even second-line option.
However, France has cancelled its order for the drug amid concerns that it is not as effective as once thought.
The Financial Times report noted that Merck is grappling with “problematic” data, with an efficacy level of 30 per cent bordering on the limits of what is considered to be beneficial.
Rival Covid-19 pill from famed vaccine maker Pfizer, Paxlovid, has an efficacy level of 89 per cent, according to European officials.
City A.M. has contacted Merck and the European Medicines Agency for comment.