(Reuters) - Merck and Co and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in the European Union, months after the region's regulator did not back the drug citing insufficient data.
Merck had requested the regulator's Committee for Medicinal Products for Human Use (CHMP) to re-examine the application for molnupiravir, which is sold under the brand Lagevrio in several countries, after CHMP advised against its market authorization in February.The agency had said the drug could not demonstrate benefits in treating COVID patients who did not need oxygen support and were at the risk of their disease worsening.
"We are evaluating our options on how we can generate additional evidence supportive of Lagevrio for the treatment of COVID-19," Merck's research head Dean Li said in a statement on Tuesday.
Merck said it was committed to continue providing Lagevrio through "compassionate or emergency use programs" authorized by individual EU member states.
Lagevrio is authorized as a COVID treatment for high-risk patients in more than 25 countries including Australia, Japan, U.S., UK and China, but its sales have slumped recently as cases have declined.
The drug's sales plummeted 88% to $392 million in the first quarter.
The pill has also suffered as it was found to be only 30% effective compared with nearly 90% effectiveness for Pfizer's COVID drug Paxlovid, as shown in separate studies.
(Reporting by Leroy Leo in BengaluruEditing by Vinay Dwivedi and Krishna Chandra Eluri)
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