The pharmaceutical company Merck has requested authorization from the US regulator to market its pill against COVID-19, called molnupiravir, according to the AP agency. It has done so after announcing a few days ago that the antiviral drug reduced the risk of hospitalization or death by approximately 50% during clinical trials developed by the company.
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Merck – known as Merck Sharp & Dohme (MSD) outside the United States and Canada – and its partner Ridgeback Biotherapeutics detailed on October 1, when announcing the results of their trials, that 7.3% of patients who were administered the oral drug were hospitalized or died after treatment (28/385), compared with 14.1 percent of placebo-treated patients (53/377). But until day 29 after treatment, there were no deaths in the patients who received molnupiravir, compared with 8 deaths in the patients who took placebo.
In terms of side effects, they were similar, according to the companies, to those suffered by those who received placebo. However, Merck did not make public the details of the adverse reactions experienced by the participants, one of the key points of the study that will now be carried out by the United States Drug Administration (FDA). The FDA will now assess that data and, according to the country’s media, could make a decision in a matter of weeks.
The interim analysis of the phase ‘3 MOVe-OUT’ trial evaluated data from 775 patients who were enrolled on or before August 5, 2021, to the study. At the time of making the decision to stop recruitment based on interim efficacy results, the trial was approaching full recruitment of the phase 3 sample size of 1,550 patients, with more than 90 percent of the predicted sample size already registered.
Orally administered molnupiravir is a ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19. The drug was invented at Drug Innovations at Emory (DRIVE), a non-profit biotechnology company wholly owned by Emory University, United States, and is being developed by Merck in collaboration with Ridgeback Biotherapeutics.
Merck has estimated that it can produce up to 10 million pills by the end of the year. Meanwhile, and although it has not yet been approved by any regulator in the world, Australia, Thailand, Malaysia, Singapore or North Korea have already anticipated and reserved doses for their population. Australia, for example, has reserved 300,000 pills of the drug and Malaysia has ordered 150,000.