The European Union's drug regulator said on Friday its Committee for Medicinal Products for Human Use has advised against market authorisation of the COVID-19 pill from Merck & Co Inc for treatment in adults.
The antiviral pill, brand named Lagevrio, could not demonstrate benefits in treatment of COVID patients who do not need oxygen support and are at risk of their disease worsening, the European Medicines Agency (EMA) said.
Merck and its partner Ridgeback Biotherapeutics said they will appeal the decision and request a re-examination of the committee's opinion.
"The CHMP's recommendation does not reflect the compelling data" from one of the company's late-stage trial and real-world studies, Dean Li, head of Merck's research division, said.
In December, a large study had shown that the drug sped up recovery but did not reduce hospitalisation or death rate in higher-risk vaccinated adults.
The regulator's recommendation against Merck's COVID-19 pill comes days after the company said Lagevrio was not effective at cutting the risk of coronavirus infections in people living with someone infected with the virus.