Episode Details

Is this antiviral a game changer, Oral Antiviral, molnupiravir https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/ Merck and Ridgeback Oral Antiviral, molnupiravir (MK-4482, EIDD-2801) Positive Interim Analysis of Phase 3 Study Significantly reduced the risk of hospitalization or death During day 1 to 5 to 29 days Phase 3 MOVe-OUT trial At risk, non-hospitalized adults with mild-to-moderate COVID-19 A global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States Eligibility criteria Laboratory-confirmed mild-to-moderate COVID-19 With symptom onset within 5 days of study randomization All patients were required to have at least one risk factor Molnupiravir group Hospitalization or dead, 7.3% of patients 28 out of 385 No deaths Placebo group Hospitalization or dead, 14.1% of patients 53 out of 377 P is 0.0012 8 deaths Data Monitoring Committee in consultation with Food and Drug Administration Recruitment into the study stopped early Due to these positive results Merck, application for Emergency Use Authorization in US Other regulatory bodies worldwide About the Results of the Planned Interim Analysis Evaluated data n = 775 Recruitment 90% of 1,550 the intended sample Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; Efficacy was not affected by timing of symptom onset or underlying risk factor About 40% of participants had sequencing data Molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu Incidence of adverse event between groups Molnupiravir group Incidence of any adverse event, 35% Drug-related adverse events, 12% Subjects discontinued study therapy due to an adverse event, 1.3% Placebo groups Incidence of any adverse event, 40% Drug-related adverse events, 11% Subjects discontinued study therapy due to an adverse event, 3.4% Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from intercourse or agree to use contraception. Women of child-bearing age in the study could (not) be pregnant and also had to use birth control. https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-covid-19-pill-cuts-risk-death-hospitalization-by-50-study-2021-10-01/ About Merck’s Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021 Existing procurement agreement with the U.S. Government Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government upon EAU $700 per 5 day course (2 doses per day) $1.2 billion purchase agreement for the 1.7 million 5-day treatment courses of molnupiravir MOVe-AHEAD A global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households

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