Xinhua News Agency, Beijing, October 2 (Reporter Peng Qian) On the 1st, Merck of the United States announced the interim analysis data of the phase III clinical trial of the oral anti-coronavirus drug monabiravir jointly developed by it and Richbarker Biopharmaceuticals.
Monabilavir is a small-molecule broad-spectrum antiviral oral drug for RNA viruses, which can inhibit the replication of the new coronavirus
In terms of safety, the incidence of any adverse events in the monabiravir treatment group was 35%, compared with 40% in the placebo group; the incidence of drug-related adverse events was 12% in the treatment group and 11% in the placebo group
Merck issued a statement that due to the positive results, based on independent data monitoring committee will advise and communicate with the US Food and Drug Administration, has been terminated early Ⅲ clinical trials, and plans to submit an Emergency Use Authorization application to the US FDA as soon as possible , And will also submit listing applications to regulatory agencies in other countries and regions around the world as soon as possible
Committee member Merck said that based on its confidence in the research results, it has begun to produce monabiravir ahead of schedule.
Ding Sheng, director of the Global Health Drug Research and Development Center and dean of the School of Pharmacy of Tsinghua University , said in an interview with Xinhua News Agency that in terms of large-scale promotion, small-molecule oral drugs such as monabiravir have more advantages and are convenient for early drug use; synthesis cost Low, can be stored at room temperature, easy to purchase and use in developing countries; can be quickly used in high-risk groups such as close contacts, to help mild patients to quickly control the condition
Dean focuses on the new crown pneumonia epidemic
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