Merck and Ridgeback’s Molnupiravir, an investigational oral antiviral COVID-19 treatment drug, received emergency approval in Japan – QNT Press Release

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Japan’s Ministry of Health, Labour and Welfare approves Molnupiravir for the treatment of SARS-CoV-2 infection

Molnupiravir, the world’s first authorized oral COVID-19 antiviral drug, is now authorized in the United States, the United Kingdom and Japan; regulatory submissions are under review worldwide

Merck (New York Stock Exchange stock code:MRK), known as MSD outside the United States and Canada, Ridgeback Biotherapeutics announced today that the Ministry of Health, Labour and Welfare of Japan has granted molnupiravir, an investigational oral antiviral drug, for the treatment of infectious diseases caused by SARS. ——Coronavirus-2. Emergency Special Approval is the process of quickly approving medical products in emergency situations to protect public health in accordance with Article 14-3 of the Drugs and Medical Devices Law.in a Previously announced According to the supply agreement, the Japanese government will purchase 1.6 million courses of monelavir to accelerate the acquisition of patients.

This press release features multimedia. View the full version here: https://www.businesswire.com/news/home/20211224005081/en/

“As a single oral drug that can be taken at home, the early treatment of monelavir significantly reduces the risk of hospitalization or death in high-risk patients who develop severe COVID-19. For patients, it is important to take the drug The death toll of patients has been significantly reduced by molnupiravir in our clinical studies. We believe that molnupiravir will be an important complement to existing measures that help curb the impact of COVID-19 on Japanese patients, the healthcare system, and public health,” said President Dean Said Dr. Y. Li, Merck Research Laboratories. “Everyone at Merck has assumed our responsibility to bring this important drug to patients around the world as soon as possible.”

“We are proud to reach this important milestone with our collaborators, patients and doctors,” said Wendy Holman, CEO of Ridgeback Biotherapeutics. “We are confident in the prospect of molnupiravir as a drug that can be taken at home without known drug interactions, and believe that it will have a positive impact as part of the global effort to fight the COVID-19 pandemic.”

Molnupiravir was the first oral COVID-19 antiviral drug authorized on November 4, when the British Medicines and Healthcare Products Regulatory Agency awarded AuthorizationIn the European Union, the European Medicines Agency issued a positive scientific opinion on monoprevir in accordance with Article 726/2004, Article 5.3, aiming to support the country’s decision on the possible use of monelavir before it is approved for marketing. On December 23, the U.S. Food and Drug Administration indeed Emergency use authorization for molnupiravir. The regulatory application is under review or is being submitted for molnupiravir worldwide.

In Japan, LAGEVRIO® (molnupiravir) is the planned trademark of molnupiravir. Molnupiravir is available as LAGEVRIO in certain markets outside the United States.

About the MOVe-OUT study

Approval is based on Positive results of planned interim analysis From the Phase 3 MOVe-OUT clinical trial (NCT04575597), the study evaluated the laboratory-confirmed mild to moderate COVID-19 at 800 mg twice a day among non-hospitalized, non-vaccinated non-hospitalized, and non-vaccinated adult patients. Symptoms appear within a day, and at least one risk factor related to an undesirable disease results (for example, heart disease, diabetes). The main efficacy goal of MOVe-OUT is to evaluate the efficacy of molnupiravir 800 mg twice daily for five days compared to placebo, based on the percentage of participants who were hospitalized and/or died to day 29.

In the interim analysis (the main analysis time point of the study), molnupiravir significantly reduced the risk of hospitalization and death: 14.1% (53/377) of the patients in the placebo group were hospitalized or died, compared to this percentage This was 7.3% (28/385) of the hospitalized patients receiving morulav; in the interim analysis, the patients who took monelavir did not die before the 29th day, while there were 8 patients who took placebo. The absolute risk reduction was 6.8 percentage points (95% CI: 2.4, 11.3; p=0.0012, unilateral). Compared with placebo, the risk of hospitalization or death from molnupiravir to day 29 was reduced by approximately 50%. In all randomized analyses (n=1433), molnupiravir had a lower risk of hospitalization or death on day 29: 9.7% (68/699) in the placebo group and 6.8% (48/709) in the placebo group. , The absolute risk is reduced by 3.0% (95% CI: 0.1, 5.9), and the relative risk is reduced by 30%. Nine deaths were reported in the placebo group (the 29-day all-cause mortality rate was 1.3%), and the monupiravir group reported 1 case (the 29-day all-cause mortality rate was 0.1%), indicating a relative reduction in the risk of death by 89% (95% CI: 14, 99).

In the molnupiravir 800 mg group, 12.4% (48/386 participants) observed adverse reactions. The most common adverse reactions observed (greater than or equal to 1%) were diarrhea 3.1% (12/386 participants), nausea 2.3% (9/386 participants), and dizziness 1.3% (5/386 participants) And headache 1.0% (4/386 participants).

About Merck’s global efforts to accelerate the acquisition of Molnupiravir after obtaining regulatory authorization or approval

Since the start of the molnupiravir collaboration, global access has been a priority for Merck and Ridgeback. The two companies are committed to providing monelavir globally in a timely manner through our comprehensive supply and acquisition methods, including venture capital to produce millions of treatment courses; tiered pricing based on the government’s ability to fund healthcare; and The government signs a supply agreement; grants voluntary licenses to generic drug manufacturers and drug patent pools, and after local regulatory authorization or approval, produces generic drug monopiravir in more than 100 low- and middle-income countries.

supply: Taking into account the results of MOVe-OUT and the possibility of obtaining authorization or approval from regulatory authorities, Merck has been producing monelavir at risk, and will produce 10 million treatment courses by the end of 2021, and at least 20 million treatment courses will be produced by 2022. To date, Merck has shipped monelavir to 14 countries; in approved or authorized countries, patients have begun to receive the drug.

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The full story can be found on Benzinga.com

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