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    Home > Active Ingredient News > Infection > The UK approves Merck's new crown oral drug molnupiravir, opening a new era of crown treatment!

    The UK approves Merck's new crown oral drug molnupiravir, opening a new era of crown treatment!

    • Last Update: 2021-11-13
    • Source: Internet
    • Author: User
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    On November 4, Merck/Ridgeback announced that the British Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing of molnupiravir (MK-4482, EIDD-2801) in the UK for the treatment of adult patients with mild to moderate COVID-19
    .


    Molnupiravir is the world's first approved for the treatment of adults with mild to moderate COVID-19 oral antiviral drugs, these patients with SARS-CoV-2 diagnostic tests were positive and there is at least a risk factor for severe disease development


    COVID-19 diagnosis

    In addition, on October 11, the EUA was also submitted to the FDA.
    It will be decided on or about November 30.
    It is likely to be approved.
    See: FDA will hold an advisory committee meeting to discuss Merck and Ridgeback's COVID-19 Oral therapy molnupiravir )
    .

    The FDA will hold an advisory committee meeting to discuss Merck and Ridgeback's oral COVID-19 treatment molnupiravir

    This approval is mainly based on data from the Phase III MOVe-OUT study
    .


    The initial treatment patients were given molnupiravir and placebo.


    Merck's oral specific drug Molnupiravir for the treatment of new coronary pneumonia has achieved good results, reducing hospitalization or mortality by 50%, and may be one of the decisive drugs for the treatment of new coronary pneumonia in the future

    In terms of safety, the incidence of any adverse events in the Molnupiravir treatment group was similar to that in the placebo group (35% vs 40%), and the incidence of drug treatment-related adverse events was also comparable (12% vs 11%)
    .


    Moreover, the proportion of patients who discontinued treatment due to adverse events in the Molnupiravir group was lower (1.


    Molnupiravir (MK-4482/EIDD-2801) is a nucleoside analog discovered by DRIVE (Drug Innovations at Emory), a non-profit organization affiliated to Emory University, which inhibits the activity of SARS-CoV-2 replication.
    It is 3-10 times higher, and has shown activity in a number of preclinical SARS-CoV-2 virus infection prevention , treatment and prevention models
    .

    Infection prevention

    Molnupiravir is currently co-developed by Merck and Ridgeback.
    Ridgeback received a down payment from Merck and will receive miles based on clinical development and registration progress in the future
    .


    In the future, the two companies will share the profits after drug sales


    On June 9 this year, Merck signed a procurement agreement with the US government.
    Once it obtains emergency use authorization or formal approval from the FDA, it will provide the US government with 1.
    7 million courses of molnupiravir
    .


    Merck has also signed procurement and supply agreements for molnupiravir with other governments around the world, and is currently communicating with more governments


    Merck promises that if Molnupiravir obtains emergency use authorization or marketing approval, it will promptly supply Molnupiravir globally, and plans to implement a tiered pricing method in accordance with the World Bank’s national income standards to reflect the direction of each country or region in response to this pandemic.
    The relative ability of public health to provide funding
    .

    As part of its commitment to widely supply globally, Merck previously announced that the company has signed a non-exclusive voluntary license agreement for Molnupiravir with mature generic drug manufacturers in order to be listed in more than 100 low- and middle-income countries (LMIC) Accelerate the supply of Molnupiravir after approval or emergency use authorization
    .

    The next concern is Pfizer PF-07321332 and Japan's Shiono Yoshihide s217622, ​​while the AT-527 developed by Roche and its partner Atea has failed
    .


    For details, see: The development of the world's top five oral drugs for the treatment of new coronavirus infections, and the future will be the main force against new coronavirus infections

    The world's five major oral treatments for the development of new coronavirus infections are progressing, and the future will be the main force against the new coronavirus

    Of course, the role of Prokalutamide in China's pioneering pharmaceutical industry is still controversial, and we need to wait for the results of the phase 3 clinical study.


    The role of procrulamide is still controversial, and we need to wait for the results of the phase 3 clinical study; in addition, another new anti-hepatitis B drug, Le Fu Neng, has also shown good results in reducing severe illness and death by 58% in the phase 3 clinical trial.
    effect (see: novaferon new crown the treatment of severe pneumonia phase III clinical trial data announced lower respiratory failure and mortality in critically ill patients of 58.
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