June 27 (Reuters) - Merck and Co (MRK.N) and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in the European Union, months after the region's regulator did not back the drug citing insufficient data.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 and Ridgeback Provide Update on EU Marketing Authorization Application for LAGEVRIO™ (Molnupiravir)
An experimental COVID-19 treatment pill, called molnupiravir and being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters May 17, 2021. Merck & Co Inc/Handout via REUTERS
RAHWAY, N.J. & MIAMI--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today issued the following announcement regarding data from two real-world evidence studies evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral COVID-19 medicine. The first study, PANORAMIC, was conducted by the University of Oxford in the UK in highly-vaccinated adults mostly less than age 65 during the period when the circulating SARS-CoV-2 variant was predominantly Omicron. The second study, Clalit, was conducted by investigators in Israel in mostly older adults with underlying chronic health conditions that make them vulnerable to severe COVID-19 disease, also when Omicron was the most dominant strain. The PANORAMIC pre-print was published today and the Clalit pre-print was published last week. Additionally, Merck is reporting results from a recent carcinogenicity study in transgenic mice, which demonstrated that LAGEVRIO was not carcinogenic at any dose tested.
Emergent BioSolution inked an agreement last week with Ridgeback Biotherapeutics in a collaboration to expand the availability of Ebola treatment Ebanga. Under the deal, Emergent will be responsible for the manufacturing, sale and distribution of Ebanga in the US and Canada. Ridgeback Bio for its part will serve as the global partner for the drug and ensure it remains available to patients in endemic countries free of charge through its compassionate use program.
RAHWAY, N.J. & MIAMI--(BUSINESS WIRE)--Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the Annals of Internal Medicine has published additional data from the Phase 3 MOVe-OUT trial evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral medicine, in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease.
An ICER committee voted (PDF) 11-2 that the evidence on molnupiravir was inadequate to demonstrate a net health benefit over symptomatic care alone. Paxlovid, for its part, won all panelists’ favor with 13 votes, while a slight majority of panelists (7 to 6) found current evidence on fluvoxamine acceptable to demonstrate benefit over symptomatic care.
Merck on Thursday soundly beat Wall Street profit and revenue forecasts, reporting earnings of $2.14 per share on $15.9 billion in revenue. The company raised its 2022 earnings guidance to between $7.24 and $7.36 per share on $56.9 billion to $58.1 billion in revenue. It previously projected earnings per share of between $7.12 and $7.27 on revenue between $56.1 billion and $57.6 billion.
Thousands more people in the U.K. will gain access to Pfizer’s Paxlovid thanks to its inclusion in the national Panoramic study, which is looking at how best to use the pill among Britain’s highly vaccinated population, the country’s Department of Health and Social Care said Tuesday.
Thousands more people in the U.K. will gain access to Pfizer’s Paxlovid thanks to its inclusion in the national Panoramic study, which is looking at how best to use the pill among Britain’s highly vaccinated population, the country’s Department of Health and Social Care said Tuesday.