CHMP Recommends Against EU Marketing Authorization for Merck's Molnupiravir; Company to Appeal Decision

Feb 25, 2023 08:11 CST Updated 08:11

MSD

Pharmaceutical R&D and Manufacturer

Ridgeback

Biotechnology Company

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

On February 24, MSD/Ridgeback Biotherapeutics jointly announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended rejecting the marketing application for the COVID-19 oral drug LAGEVRIO (Molnupiravir). The two companies will appeal the decision and request a re-examination of CHMP's opinion.

CHMP considers that there is insufficient evidence to prove that Molnupiravir provides clinical benefit to patients with mild to moderate COVID-19 who do not require supplemental oxygen and are at high risk of progressing to severe disease.

Previously, MSD announced the results of the Phase III MOVe-OUT clinical trial involving 1,433 patients. This study evaluated the efficacy and safety of Molnupiravir 800mg twice daily in non-hospitalized adult patients with mild to moderate COVID-19 who were unvaccinated. The results showed that 9.7% (68/699) of patients in the placebo group were hospitalized or died, while 6.8% (48/709) of patients in the Molnupiravir group were hospitalized, with an absolute risk reduction of 3.0% (95% Confidence Interval [CI]: 0.1, 5.9). There were 9 deaths reported in the placebo group and 1 death reported in the Molnupiravir group.

Molnupiravir is an oral nucleoside analog that inhibits the replication of the SARS-CoV-2 virus. On November 4, 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Molnupiravir for the treatment of adult patients with mild to moderate COVID-19 who have tested positive for SARS-CoV-2 and have at least one risk factor for developing severe illness. This marked the first global approval of Molnupiravir, making it the world's first approved oral antiviral drug for COVID-19. By the end of December 2022, Molnupiravir was conditionally approved for marketing in China.

"We believe that the CHMP opinion does not reflect the compelling data from the Phase III MOVe-OUT study and real-world studies, which show that LAGEVRIO can reduce the risk of hospitalization or death and provide a positive impact for patients," said Dr. Dean Y. Li, President of Merck Research Laboratories. "More than 4 million patients worldwide have been treated with LAGEVRIO. We remain confident in the important role LAGEVRIO can play in the treatment of COVID-19 and will appeal this opinion."

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position; if you need to reprint, please leave a message to the WeChat Official Account's backend or send a message, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.