The findings reported on a secondary objective to reduce time to negativity of infectious SARS-CoV-2 virus isolation from nasopharyngeal swabs from participants with symptomatic COVID-19 Primary and other secondary findings to be presented at an upcoming medical meeting Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics, LP today announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent. The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. These preliminary findings were presented
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Phase 3 MOVe-OUT Study of Molnupiravir in Outpatients to Proceed, Phase 2/3 MOVe-IN Study in Hospitalized Patients Will Not Proceed Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the clinical development program for molnupiravir (MK-4482/ EIDD-2801), an investigational orally available antiviral therapeutic. Based on a planned interim analysis of data from the Phase 2, dose-finding portion (Part 1) of two ongoing placebo-controlled Phase 2/3 trials evaluating molnupiravir administered twice a day for five days in outpatients (MOVe-OUT) and hospitalized patients (MOVe-IN) with COVID-19, and from a previously completed Phase 2a dose-ranging study in outpatients, the decision has been made to proceed with the Phase 3 portion (Part 2) of MOVe-OUT in outpatients with COVID-19, evaluating the 800 mg dose of molnupiravir twice daily. Data from MOVe-IN indicate that molnupiravir is unlikely to demonstrate a
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:
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that new Phase 3 data for molnupiravir, an investigational oral COVID-19 antiviral medicine, will be presented as a late-breaking poster (#LB-5319) at the American Society of Tropical Medicine and Hygiene (ASTMH) 2021 Annual Meeting taking place virtually from Nov. 17-21. Poster data will be available on Wednesday, Nov. 17 at 9 a.m. ET and presented during Poster Session C from 11 a.m.-12:30 p.m. ET on Saturday, Nov. 20. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211117005607/en/ The presentation will include data from the molnupiravir clinical development program, with an emphasis on the interim results from the MOVe-OUT trial, including baseline characteristics of study population and additional details on efficacy and safety. The companies previously announced positive results from a planned interim
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
Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. For more information on the molnupiravir MOVe-AHEAD clinical trial, visit http://merckcovidresearch.com/move-ahead/ or www.clinicaltrials.gov . “As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease,” said Dr. Nick Kartsonis,
If Granted Marketing Authorization by the European Commission, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19 in the European Union Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. As previously announced , Merck has submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA), and is actively working to submit applications to other regulatory agencies worldwide. This press release features multimedia. View the full release here:
If Authorized, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19 Submissions to Regulatory Agencies Worldwide Underway Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral 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. The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211011005110/en/ The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which
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
Japan’s Ministry of Health, Labor and Welfare Approves Molnupiravir for the Treatment of SARS-CoV-2 Infection Molnupiravir, First Oral COVID-19 Antiviral Medicine To Receive Authorization in the World, Now Authorized in U.S., U.K. and Japan; Regulatory Submissions Are Under Review Around the World Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Japan’s Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. Special Approval for Emergency is the process under Article 14-3 of the Pharmaceuticals and Medical Devices Act to approve a medical product swiftly in an emergency situation to protect public health. Under a previously announced supply agreement, the Japanese government will purchase 1.6 million courses of molnupiravir to accelerate access to patients. This press release