Health & Beauty

The US pharmaceutical giant Merck and its partner Ridgeback Biotherapeutics announced on October 11 that it had submitted an emergency use authorization application to the US Food and Drug Administration (FDA) for its new crown oral drug Molnupiravir (Molnupiravir).

If successfully authorized, monupivir will become the first oral antiviral treatment against the new crown virus, used to treat mild to moderate adult patients with new crowns who are at risk of developing severe or hospitalization. Previously, the antiviral drug Remdesivir, which has received much attention, and the new crown neutralizing antibody drugs approved by Junshi Biologics, Eli Lilly and Regeneron, etc. in the United States, were all injected and used in a hospital environment.

Merck announced that this application is based on the positive results of the MOVe-OUT Phase III clinical trial. In the results of the interim analysis, the patient's risk of hospitalization or death was reduced by approximately 50%. 7.3% of patients treated with monupivir were hospitalized or died on the 29th day after randomization, while the proportion of patients treated with placebo was 14.1%. By day 29, there were no reports of deaths among patients receiving monupivir, while 8 patients receiving placebo had died. null of the volunteers in the trial had been vaccinated.

In terms of safety, there was little difference in the incidence of any adverse events between the monupivir group and the placebo group, which were 35% and 40%, respectively. The incidence of drug-related adverse events was also similar, at 12% and 11%, respectively. In addition, fewer subjects in the monupivir group withdrew from treatment due to adverse events. The withdrawal rate was 1.3% in the monupivir group and 3.4% in the placebo group.

It is worth noting that monupivir is not effective for critically ill patients. In April of this year, because the data was not as good as expected, Merck announced that it would terminate the phase II/III study of monupivir in severely ill inpatients, but continue to advance the phase III study in mild to moderate outpatients.

However, from the clinical trial data, monupivir has a significant effect on patients with mild new coronary disease. Therefore, in the future, the prevention and control of the new crown is expected to emerge a multi-level prevention and control method of "vaccine + antiviral drug + neutralizing antibody", which will further accelerate the end of the pandemic.

According to CNN, Dr. Leana Wen, a former Baltimore City Health Commissioner and CNN Medical Analyst, said that having an antiviral drug that can prevent the new coronavirus infection from becoming serious is "critical." The current drugs all need to be injected, which is a burden for both the individual and the medical system. If patients are able to take pills at home in the early stage of treatment when a mild infection is diagnosed, it will reduce the burden on the medical system and help individuals prevent the disease. In addition, Myron Cohen, a professor of epidemiology at the University of North Carolina who was involved in the study of monupivir, said in an interview with CNN that the goal of research and development is that monupivir can inhibit the replication of the virus in the human nasal cavity, thereby reducing the transmission of the virus by the infected person. risks of.

Based on confidence in the research results, Merck has already started production of monupivir ahead of schedule, and is expected to produce 10 million treatment courses by the end of this year, and will continue to increase its supply in 2022. In June of this year, the US government has signed a $1.2 billion contract with Merck, which will supply 1.7 million courses of medication at a price of $712. The transaction will take place immediately after monupivir obtains an emergency use authorization from the FDA.

Merck also stated that if the emergency use right of monupivir is approved, it will be supplied globally. It plans to implement a tiered pricing method based on the World Bank’s national income standards and will cooperate with generic drug manufacturers to accelerate the supply of low- and medium-income products. nation.