Health Times reporter Tan Qixin
On October 6, a preliminary analysis of data from a latest real-world study jointly released by Merck and partners showed that there is no evidence that oral antiviral drug monupiravir (molnupiravir) can reduce hospitalization and mortality on the 28th day.
A total of 25,783 subjects were included in the study, and more than 98% of the subjects were vaccinated with the new crown vaccine . During the trial, the subjects were randomly assigned to receive open-label treatment with monupivir plus routine care, or open-label treatment with conventional care alone. Preliminary analysis of study data showed that the primary endpoints for hospitalization and death reduction within 28 days after randomization were not met compared to routine care alone.
Real-world PANORAMIC research data publishing page screenshot.
According to Merck's official information, monupivir is a new crown drug jointly developed by Merck and its partner Ridgeback Biotherapy. It is also the world's first new crown oral drug approved for the treatment of mild to moderate adult patients. It was approved for marketing in the UK on November 4, 2021 and was urgently authorized by the U.S. Food and Drug Administration (FDA) on December 23, 2021. At present, monupivir has obtained marketing authorization or emergency use authorization in more than 20 countries or regions around the world.
According to information released by the official website of the US FDA, emergency authorization is based on a Phase III clinical trial study called MOVe-OUT. The research results released at the end of 2021 showed that after evaluating the data of 775 subjects, it was found that in terms of efficacy and safety, monupivir can reduce the risk of hospitalization/mortality by 30% (6.8% vs 9.7%).
However, some industry insiders pointed out to Health Times that emergency authorization is different from formal approval. Emergency authorization is more of a temporary decision made by the drug regulatory authorities after reviewing the limited clinical evidence that the drug can provide, and believes that the potential benefits of the drug exceed the potential risks. ", but this also means that the benefits and risks of the drug have not been clarified yet, and it is still a long way from the official approval of the market. Especially in the current situation of accelerated mutation of the new coronavirus, the complete data of a larger population needs to be updated and supplemented. "
It is worth noting that in the new coronavirus treatment guideline (10th edition) updated by the World Health Organization on April 22, monupivir was included in the first recommendation for the treatment of non-severe COVID-19 patients, especially for patients with the highest hospitalization risk. However, WHO also pointed out that since the efficacy and long-term harm of monupivir on mutant viruses are still uncertain, it is only recommended for use under weak/special conditions.
According to public information, Merck has submitted an application for monupivir to the Chinese drug regulatory department in June this year. What is the current progress of listing in my country? Will the real-world research data disclosed this time have an impact on the global fight against the epidemic? A Health Times reporter sent a question to Merck's official email on October 8, but no reply was received as of press time.
