EU drug regulator advices against market nod for Merck COVID pill Lagevrio for adults

Published On 2023-02-26 10:15 GMT   |   Update On 2023-02-26 10:16 GMT

US: 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,...

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US: 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.

Read also: Moderna-Merck gets USFDA Breakthrough Therapy Designation for personalized mRNA cancer vaccine in combination with KEYTRUDA to treat high risk melanoma

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

Read also: USFDA removes COVID test requirements for Merck, Pfizer pills



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Article Source : Reuters

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