RAHWAY, N.J. & MIAMI – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that they have withdrawn the EU application for marketing authorization of LAGEVRIO™ (molnupiravir), an investigational oral antiviral COVID-19 medicine, following Merck’s request for re-examination of the CHMP recommendation in February for refusal of marketing […]
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Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for LAGEVRIO™ (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion. “We believe the CHMP’s recommendation does not reflect the compelling data generated from the Phase 3 MOVe-OUT trial and from real-world studies demonstrating the positive impact that LAGEVRIO can provide for patients by reducing the risk of hospitalization and death among adults at increased risk for severe disease,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “More than 4 million patients worldwide have been treated with LAGEVRIO. We remain confident that LAGEVRIO has an
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LAGEVRIO™ (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19. The Phase 3 MOVe-AHEAD trial evaluated people who did not have COVID-19 at baseline (confirmed by a negative baseline SARS-CoV-2 test and no signs and symptoms) but lived with someone who was recently diagnosed with COVID-19. In the primary endpoint of participants who did not have evidence of SARS-CoV-2 infection at baseline (confirmed by a negative SARS-CoV-2 test), the LAGEVRIO treated group was observed to be 23.6% less likely than those who received placebo to develop COVID-19 through Day 14 (a positive post-baseline SARS-CoV-2 test with evidence of signs and symptoms); the primary endpoint was not met. The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported
A preliminary analysis of the University of Oxford’s open label, prospective real-world evidence study, PANORAMIC, conducted in the UK in highly-vaccinated adults mostly <65 years of age, showed no evidence of a difference between LAGEVRIO added to usual care compared to usual care alone for the reduction of hospitalizations and deaths through Day 28 (primary endpoint was not met); the incidence of hospitalizations and death through Day 28 was very low overall (0.8% in both groups). The main secondary endpoint (time to first self-reported recovery) in the PANORAMIC study was 6 days shorter with the LAGEVRIO group compared to the usual care group; in addition, the use of LAGEVRIO also was associated with earlier recovery across a wide range of other symptom measures, as compared to the usual care group. An analysis of real-world data from a separate observational, retrospective study conducted by investigators in Israel (known as the Clalit study) showed that in a cohort of
Based on Prespecified Exploratory Endpoints, a Lower Proportion of Participants Treated With LAGEVRIO Had an Acute Care Visit Compared to Those Who Received Placebo Based on a Post Hoc Analysis, Fewer Required Respiratory Interventions (Including Invasive Mechanical Ventilation) 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. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220607005398/en/ Analyses of pre-specified exploratory endpoints indicate that a lower proportion of LAGEVRIO-treated participants in the modified intent-to-treat (MITT) population had an acute care visit or a
Additional Exploratory Patient Subgroup and Virology Data from MOVe-OUT Presented at ECCMID Among Patients With Infectious Virus at Baseline, No Patients Who Received LAGEVRIO Had Infectious Virus at Days 3, 5 or 10 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that data evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral COVID-19 medicine, will be presented at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) (Abstract #4514). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220401005097/en/ The presentation includes final analyses evaluating virologic outcomes throughout and following a five-day course of LAGEVRIO as part of the Phase 3 MOVe-OUT trial, which studied LAGEVRIO versus placebo for the treatment of COVID-19 in non-hospitalized adults with mild to moderate COVID-19 who were at high risk
Merck Has Completed Manufacturing of 10 Million Courses of Therapy and Remains on Track to Produce at Least 20 Million Courses in 2022 to Provide Widespread Access to Molnupiravir Globally Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that a total of approximately 3.1 million courses of molnupiravir, an investigational oral antiviral COVID-19 medicine, have been provided to the U.S. government for allocation across the country. The U.S. Department of Health and Human Services (HHS) has created a public website to help providers identify locations that have received shipments of government-procured COVID-19 therapeutics available under Emergency Use Authorization. In 2021, Merck entered a procurement agreement with the U.S. government under which the company agreed to supply approximately 3.1 million courses of molnupiravir to the U.S. government upon Emergency Use Authorization or approval from the U.S. Food and
Merck Allocates 3 Million Courses of Molnupiravir to be Provided in First Half of 2022 for Use in Low- and Middle-Income Countries Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the signing of a long-term supply agreement with the United Nations Children’s Fund (UNICEF) to facilitate broad global access for molnupiravir, an investigational oral antiviral COVID-19 medicine. Under the agreement, Merck will allocate up to 3 million courses of molnupiravir to UNICEF throughout the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorizations. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics and it has been authorized for use in more than 10 countries, including in the United States, United Kingdom and Japan. “Merck is delivering on our commitment to make molnupiravir available – widely, quickly and equitably. Through this
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced data from six preclinical studies demonstrating that molnupiravir, an investigational oral antiviral COVID-19 medicine, was active against the SARS-CoV-2 variant Omicron (B1.1.529) in vitro. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220128005096/en/ “These findings from multiple independent in vitro studies showing that molnupiravir has consistent antiviral activity against Omicron, the primary variant circulating globally, provide additional confidence in the potential of molnupiravir as an important treatment option for certain adults with mild to moderate COVID-19 who are at high risk for progressing to severe disease,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are grateful to these investigators for these important insights, and to our own colleagues who are working with global
Merck and Ridgeback Statement on Clinical Trial of Hetero’s Generic Molnupiravir
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today issued the following statement regarding the clinical trial of Hetero’s generic molnupiravir. Merck is developing molnupiravir, an investigational oral antiviral COVID-19 medicine, in collaboration with Ridgeback Biotherapeutics and it has been authorized for use in more than 10 countries, including […]