Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211216006079/en/ Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European
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Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the MOVe-OUT study of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine for COVID-19. Data are now available from all enrolled participants (n=1433). In this study population, molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9; nominal p-value=0.0218) and a relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49, 0.99). Nine deaths were reported in the placebo group, and one in the molnupiravir group. The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005279/en/ Based on
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
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the Japanese government will purchase, upon authorization or approval, approximately 1.6 million courses of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck’s applications for the potential authorized use of molnupiravir are under review by Japan’s Pharmaceuticals and Medical Devices Agency, the U.S. Food and Drug Administration , and the European Medicines Agency . Molnupiravir is authorized in the United Kingdom for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211110005792/en/ “We are proud to partner with the Japanese
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 […]
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
At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir, an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), for approximately $1 billion. With these exercised options, the U.S. government has now committed to purchase a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022. The U.S. government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. This press release features multimedia. View the full release here:
U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Adults With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Risk Factor for Developing Severe Illness Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., LAGEVRIO ® (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark
Merck, Ridgeback Biotherapeutics and Emory University Will Not Receive Royalties for Sales of Molnupiravir Under this Agreement for as Long as COVID-19 Remains Classified as a Public Health Emergency of International Concern by the World Health Organization Collaboration Continues Merck’s Long Track Record of Making Its Medicines and Vaccines Accessible and Affordable Globally This is the First MPP Agreement to Provide Access for a COVID-19 Medical Technology The Medicines Patent Pool (MPP) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following