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Merck, Ridgeback Biotherapeutics withdraw COVID pill Molnupiravir application in EU

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-06-30T10:00:01+05:30  |  Updated On 30 Jun 2023 10:00 AM IST
Merck gets USFDA Priority Review for application for Keytruda plus standard of care as Perioperative treatment for Resectable Locally Advanced Head, Neck Squamous Cell Carcinoma
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Merck and Co and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in the European Union, months after the region's regulator did not back the drug citing insufficient data.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.

Read also: LAGEVRI did not demonstrate statistically significant reduction in COVID risk following household exposure to another individual with COVID: Merck



merckmerck newsridgeback biotherapeuticsCOVID 19coronaviruscovid drugmolnupiravirLagevrio
Source : Reuters
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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