Merck and Ridgeback Announce EMA Rolling Review of Molnupiravir for COVID-19 Treatment Amid Global Pandemic Surge
Oct 26, 2021 01:10
CST Updated
01:10
MSD
Pharmaceutical R&D and Manufacturer
Ridgeback
Biotechnology Company
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
October 25, 2021 /BioonBIOON/ --Currently, the overseas COVID-19 epidemic continues to spread rapidly. According to Baidu's "Real-time COVID-19 EpidemicBig DataReport》，as of 22:00 on October 25, 2021, the global cumulative confirmed casesmore than240 million cases (244.55 million), deaths exceeded 4.966 million.
Recently, Merck & Co. and Ridgeback Biotherapeutics jointly announced,The European Medicines Agency (EMA) has initiated a rolling review of molnupiravir (MK-4482/EIDD-2801)., this drug is an investigational`Oral antiviral medication for the treatment of adult patients with COVID-19`MSD plans to collaborate with the EMA Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process, facilitating the initiation of the formal review of the Marketing Authorisation Application.If marketing authorization is granted,Molnupiravir will become the first oral antiviral drug for the treatment of COVID-19 in the European Union.
Earlier this month, MSD has submitted to the U.S. Food and Drug Administration (FDA) submitted molnupiravir'sEmergency Use Authorization (EUA)Application: For the treatment of mild to moderate COVID-19 in adult patients at risk of progression to severe COVID-19 and/or hospitalization. The company is actively submitting applications to other regulatory authorities worldwide.
Molnupiravir is an oral antiviral drug., currently being jointly developed by MSD and Ridgeback Biotherapeutics, with both parties actively collaborating with regulatory authorities worldwide.
Dr. Dean Y. Li, Executive Vice President and President of Merck Research Laboratories, said: "The submission to the EMA marks another step in our efforts to make molnupiravir available to patients worldwide. We believe molnupiravir will be an important addition to the range of public health tools against COVID-19, including vaccines developed by the pharmaceutical industry, which remain essential as the first line of defense against this pandemic."
Regulatory application for molnupiravir, based on Phase 3 MOVe-OUTClinical TrialPositive results from the interim analysis. The trial evaluated the efficacy and safety of molnupiravir in adult patients with mild to moderate COVID-19 who are at risk of progression to severe COVID-19 and/or hospitalization.
Interim analysis showed that,Compared with placebo, molnupiravir treatment reduced the risk of hospitalization or death by approximately 50%. Through day 29 after randomization, 7.3% of patients in the molnupiravir group had been hospitalized or had died (28/385), compared with 14.1% (53/377) in the placebo group, a statistically significant difference (p=0.0012). Through day 29, no deaths were reported in the molnupiravir group, whereas 8 deaths occurred in the placebo group.
Regarding safety, the incidence of adverse events was comparable between the molnupiravir treatment group and the placebo group (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively); fewer patients in the molnupiravir treatment group discontinued treatment due to adverse events compared with the placebo group (1.3% and 3.4%, respectively).
Chemical structure of molnupiravir (Image source: scinexx.de)
Molnupiravir is a potent, orally administered ribonucleoside analogue that inhibits the replication of multiple RNA viruses, including novel coronavirus (SARS-CoV-2), the pathogen responsible for COVID-19.Molnupiravir has demonstrated activity in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, and has also shown activity in preclinical models of SARS-CoV-1 and MERS.
MOVe-OUT (MK-4482-002; NCT04575597) is a global Phase 2/3, randomized, placebo-controlled, double-blind, multicenter study enrolling non-hospitalized adult patients (aged ≥18 years) with laboratory-confirmed mild-to-moderate COVID-19 who were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and experienced symptom onset within 5 days prior to randomization.
The Phase 3 portion of this trial was conducted globally, with patients randomized in a 1:1 ratio to receive oral molnupiravir (800 mg) or placebo twice daily for 5 days. The primary efficacy endpoint was to evaluate the efficacy of molnupiravir versus placebo based on the percentage of patients hospitalized and/or who died from randomization through Day 29.
In this trial, the most common risk factors for poor disease prognosis included obesity, advanced age (>60 years),Diabetesand heart disease. The Delta, Gamma, and Mu variants accounted for nearly 80% of the baseline viral variants sequenced at the interim analysis. Patients enrolled from Latin America, Europe, and Africa accounted for 56%, 23%, and 15% of the study population, respectively. (Bioon.com)