The German pharmaceutical giant Merck presents the anti-Covid pill and announces that it will ask “as soon as possible” for emergency authorization in the US, where deaths from Coronavirus meanwhile have exceeded 700,000. The drug promises to halve the risk of hospitalizations for high-risk people.
It will arrive “as soon as possible” the request for emergency authorization in the USA for the first antiviral against Covid that it can be easily taken from home, like any other pill drug. But in the meantime, thanks to the results of a study that promises to halve the risk of hospitalizations and deaths in high-risk people, production has already begun. And, while the stock of the pharmaceutical company Merck (known as MSD in Italy) flies on the stock exchange in New York, speaking of “promising results to be carefully evaluated” is the Director of Prevention of the Ministry of Health Gianni Rezza. The new oral antiviral molnupiravir works by inhibiting the replication of many viruses (including Sars-CoV-2) and works by inserting itself into the viral RNA and causing mutations in the virus that lead to a ‘catastrophe of viral error.
The pill is taken for five days, four tablets a day. The phase III study (interim analysis) conducted in 750 people showed that it can reduce the risk of hospitalization or death by 50% in adult patients at risk and with mild or moderate Covid-19, when given in the early stages of the infection. According to the results, announced by Merck (MSD) together with its partner Ridgeback Botherapeutics, in fact, 7.3% of patients who received molnupiravir were hospitalized or died within 29 / mo, compared to a 14.1 % which was observed in patients treated with placebo. In addition to not causing particular adverse effects, it has shown an important efficacy against the viral variants Gamma, Delta and Mu.
Based on these data, the company “intends to request an emergency use authorization from the Food and Drug Administration as soon as possible”, the US regulatory body, and at the same time, “to apply for a marketing authorization to other regulatory agencies worldwide ”. The confidence in a successful and rapid process led Merck to start producing the drug before even obtaining the results of the study, assuming the entire risk: the goal is to produce 10 million doses by the end of 2021. The company has also entered into an agreement with the US government under which, once the drug is approved, it will provide approximately 1.7 million doses of molnupiravir. Purchase and supply agreements are in place with other governments worldwide and the intention is to adopt a differentiated pricing policy based on the World Bank’s income criteria. Furthermore voluntary non-exclusive licensing agreements have already been signed with generics producers, thus accelerating the availability of the pill in more than 100 low- and middle-income countries.
«The results are promising, we need to watch them carefully. Because we also need antivirals ”, commented Gianni Rezza. “We already have vaccines and monoclonal antibodies available – he added – but there are still no antivirals. It is not easy to develop an antiviral for a virus that, unlike others, replicates quickly and from an extremely acute disease “, but having it” would allow us to have a portfolio of tools that make us able to fight “a virus that” it is becoming endemic ». But, Rezza recalled, “there are several antiviral drugs being studied in phase three”. For example, the American pharmaceutical company Pfizer has started a medium to long-term study to test its oral drug for the prevention of Covid-19 among those who have been exposed to the virus. The Swiss Roche is also in the race.
The first large-scale effect of molnupiravir was: far volare Merck a Wall Street. Stocks surged to 12% yesterday, the biggest jump since 2009. Merck finished strong on Wall Street, gaining 8.4%, in what is still the largest increase in five years. Merck’s jump is accompanied by Pfizer’s 0.26% decline, Moderna’s -11.37% and Novavax’s -12.21%.
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