The Phase 3 study of Molnupiravir, published in the New England Journal of Medicine by Merck and Ridgeback

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The Phase 3 study of Molnupiravir, an investigational oral antiviral COVID-19 treatment, has been published in the New England Journal of Medicine by Merck and Ridgeback.

Merck, also known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today that the results of 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 were published in the New England Journal of Medicine. Early treatment with molnupiravir reduced the risk of hospitalisation or mortality in high-risk, unvaccinated adults with COVID-19, according to MOVe-OUT data. Molnupiravir is being developed by Merck in conjunction with Ridgeback Biotherapeutics.

“In MOVe-OUT, molnupiravir significantly reduced the risk of hospitalization and death among a diverse population of patients at risk for more severe COVID-19. The increases in COVID-19 cases, hospitalizations and deaths being reported globally are a stark reminder that new tools are urgently needed, which is why we are moving with speed and rigor to obtain authorizations and to accelerate broad global access to this investigational medicine for appropriate patients. Importantly, we observed consistent efficacy among patients with more common variants at the time, and more recent preclinical evidence indicates that molnupiravir has antiviral activity against Omicron, which is encouraging considering the uncertain future of a rapidly evolving virus such as SARS-CoV-2,”

said Dr. Dean Y. Li, president, Merck Research Laboratories.

“The publication of these positive results in the New England Journal of Medicine demonstrates that molnupiravir, which was studied as a single medicine that can be taken at home – regardless of food intake, with no known drug-drug interactions and without required dose modifications for those with kidney or liver impairment – has the potential to be a valuable addition to the therapeutic options available to fight COVID-19. We are grateful for the efforts of the clinical trial participants and investigators and will continue to study molnupiravir for the treatment and prevention of COVID-19,”

said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.

“One of the hallmarks of the MOVe-OUT study is the diverse patient population, which included adults from 20 countries, with one or more risk factors such as obesity, advanced age, diabetes and serious heart conditions. Based on this study, molnupiravir has the potential to have a meaningful impact for patients, healthcare systems and public health,”

said Dr. Monica Gomes, Universidade Federal do Paraná, Brazil.

Molnupiravir is the very first oral antiviral to be approved for the treatment of mild to moderate COVID-19 in people with a positive SARS-CoV-2 diagnostic test and at least one risk factor for severe illness in the United Kingdom. Under Article 5.3 Regulation 726/2004, the European Medicines Agency (EMA) gave a favourable scientific opinion for molnupiravir, which is designed to assist national decision-making on the potential use of molnupiravir prior to marketing authorization. Regulatory applications are being reviewed or submitted, including applications for Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) and the Ministry of Health, Labor and Welfare of Japan.

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