The production of theantiviral against Covid-19 of the pharmaceutical company Merck (known as MSD in Italy) who will ask “as soon as possible” the request for emergency authorization to the Food and Drug Administration, the US regulatory body. It is a drug that can be taken easily from home, like any other pill. To talk about “promising results to be underestimated carefully “is the Director of Prevention of the Ministry of Health Gianni Rezza. The new oral antiviral molnupiravir works by inhibiting many viruses (including Sars-CoV-2) and functioning in viral RNA and causing mutations in the virus that result in a “viral error catastrophe”.
The phase III study (interim analysis) conducted on 750 people showed that reduce the risk of hospitalization or death by 50% adult patients at risk and with mild or moderate Covid-19, given in the early stages of infection. According to the results, announced by Merck (MSD) together with partner Ridgeback Botherapeutics, in fact, 7.3% of patients who received molnupiravir were hospitalized or died within the 29th day, compared to 14.1% who it was observed in patients treated with placebo. In addition to no particular adverse effects, it has shown a ‘imported effectiveness against variants Viral Gamma, Delta and Mu.
The pharmaceutical company intends to apply for a marketing authorization not only in the United States but also to other regulatory agencies worldwide. Confidence in a successful and rapid process led Merck to begin manufacturing the drug before even obtaining the results of the study, fully assuming the risk.
“The results are promising, we must see them carefully. Because we also need antivirals “, commented Gianni Rezza.” We already have vaccines and monoclonals available, but there is still a lack of antivirals. It is not easy to develop an antiviral for a virus that, unlike others, replicates quickly and from extremely acute disease “, but it would” allow for a portfolio of tools that enable us to fight “a virus that” is endemizing “. But, Rezza recalled,” there are several antiviral drugs being studied in phase three. “
The antiviral pill manufactured by Merck, “could really a turning point in the fight against Covid “and” if administered in the first phase of the disease it could reduce hospitalization “, he says Giovanni Maga, director of the Institute of Molecular Genetics of the Cnr of Pavia, atAgi agency. “It is an antiviral in the strict sense, unlike the other three drugs recently approved by Aifa that regulate the anti-inflammatory response”, explains Maga, according to which “at the moment the safety profile is very good”.
“From the analysis of the data reviewed in Interim Analysis 4, it emerged a clear validity of the study drug in reducing cases of hospitalization and / or death by approximately 50%.” The director of the infectious disease clinic of theSan Martino hospital in Genoa, Matteo Bassetti. “At San Martino we were the first and only Italian center that enrolled a patient in the study. Soon – concludes the Genoese infectious disease specialist – we will therefore have a new opportunity to treat patients with Covid in a home. Long live research and science“.