Economic Observer Network reporter Qu Yixian On October 2, Merck announced that the interim analysis of its antiviral oral drug Molnupiravir (MK-4482, EIDD-2801) had achieved positive results. Compared with the drug, this drug reduces the risk of hospitalization or death by about 50%.
Due to the positive results, recruitment for this study was terminated early. Merck plans to submit an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) as soon as possible, and plans to submit marketing applications to many regulatory agencies around the world.
At the same time, for Molnupiravir, Merck expects to produce 10 million treatment courses by the end of 2021, and is expected to produce more doses in 2022, with tiered pricing in different countries.
Haitong Pharmaceutical stated at an interpretation meeting on October 3 that the new crown oral small molecule drugs are a useful supplement to vaccines and neutralizing antibodies. The effective oral small molecules of the new crown will greatly reduce the burden of new crown diseases, and the epidemic will continue to break out in stages. But the new crown “pandemic” state is expected to end.
Is expected to become the first oral drug for the new crown
If authorized, Molnupiravir is expected to become the first oral antiviral drug for the treatment of new coronary pneumonia.
Molnupiravir was jointly developed by Merck and Ridgeback Biotechnology Company. The above-mentioned phase 3 study is named MOVe-OUT clinical trial. This is a global multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial study with subjects Laboratory-confirmed non-hospitalized adult patients with mild to moderate new coronary pneumonia have at least one risk factor related to poor prognosis of the disease (such as obesity, advanced age (>60 years), diabetes, and heart disease), and before randomization Symptoms appeared within 5 days.
The primary efficacy endpoint of MOVe-OUT is to evaluate the efficacy of Molnupiravir by comparing the percentage of subjects hospitalized and/or died from randomization to day 29 between the Molnupiravir group and the placebo group.
The interim analysis evaluated data from 775 patients initially enrolled in the Phase 3 MOVe-OUT clinical trial on and before August 5, 2021. On the recommendation of the Independent Data Monitoring Committee and after consultation with the FDA, the recruitment for this study was terminated early due to positive results.
When the decision to stop recruitment was made based on the mid-term efficacy results, the trial was close to completing the recruiting number (phase 3 sample size is 1550 patients), and more than 90% of the expected samples have been included in the group.
In the interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50%; as of the 29th day, among patients treated with Molnupiravir, 7.3% of the patients were hospitalized or died between the randomization period and the 29th day (28 /385), and the proportion of patients receiving placebo was 14.1% (53/377).
As of day 29, there were no reports of deaths among patients receiving Molnupiravir, while 8 deaths were reported among patients receiving placebo.
The results showed that in all key subgroups, Molnupiravir reduced the risk of hospitalization and/or death; the efficacy was not affected by the time of symptom onset or potential risk factors. In addition, according to subjects with available virus sequencing data (about 40% of subjects), Molnupiravir showed consistent efficacy in different virus variants Gamma, Delta and Mu.
In terms of safety, the incidence of all adverse events was similar in the Molnupiravir group and the placebo group (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events is also comparable (12% and 11%, respectively). Fewer subjects in the Molnupiravir group (1.3%) discontinued study treatment due to adverse events than the placebo group (3.4%).
Supply and distribution
Earlier this year, Merck and the U.S. government reached a procurement agreement, according to which, after Molnupiravir received emergency use authorization or marketing approval from the FDA, Merck will supply approximately 1.7 million treatment courses to the U.S. government. In addition, Merck has signed Molnupiravir supply and purchase agreements with governments of many countries around the world, waiting for the authorization of regulatory authorities, and is currently negotiating with many countries.
Merck also promised that if Molnupiravir is authorized or approved, it will promptly supply Molnupiravir globally, and plans to implement a tiered pricing method based on the World Bank’s national income standards. This standard will reflect the public’s response to this pandemic. The relative ability of health to provide funding.
In fact, in April this year, Merck has announced that it has signed non-exclusive voluntary licensing agreements for Molnupiravir with five Indian generic drug manufacturers, allowing them to produce and sell Molnupiravir to more than 100 low- and middle-income countries. , In order to speed up the supply of Molnupiravir after obtaining marketing approval or emergency use authorization in these low- and middle-income countries.
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