MOLNUPIRAVIR. According to clinical trials by the American laboratory Merck, treatment with molnupiravir in pill form halves the risk of developing a severe form of Covid-19. The European Medicines Agency has launched the accelerated examination procedure for the pill and France has placed its first order with the Merck laboratory.
[Mis à jour le mardi 26 octobre 2021, à 16h52] France has ordered 50,000 doses of molnupiravir produced by Merck, announced the Minister of Health, Olivier Véran, this Tuesday, October 26, during a hearing in the Senate. This treatment, which could halve the risks of hospitalization for patients who have just been tested positive for Covid-19, will be delivered “to France from the last days of November or the first days of December”, specified the minister. Olivier Véran did not specify the cost of the order, but, for example, the United States ordered 1.7 million doses for $ 1.2 billion – or about $ 700 per dose. . It therefore seems that the cost of treatment is particularly high. Considering the cost, the drug is unlikely to be put into the French pharmacy for wide distribution, it will certainly require a well-justified prescription.
The Merck laboratory’s Covid-19 pill, developed by the Ridgeback Biotherapeutic laboratory, will undergo an accelerated examination procedure in Europe, announced the European Medicines Agency (EMA) on Monday, October 25. in a press release. The agency effectively said: “The EMA’s Committee for Medicinal Products for Human Use (CHMP) has launched an ongoing review of the oral antiviral drug molnupiravir […] developed by Merck […] for the treatment of Covid-19 in adults “, which makes it possible to speed up the procedure. If approved, this remedy – easy to administer, since it is intended to be ingested – would mark a major advance in the fight for reduce severe forms of the disease, and might become an indispensable tool in the fight against the pandemic.
The EMA clarified that preliminary results from laboratory studies and clinical studies on the treatment “suggest that the drug may reduce the capacity of SARS-CoV-2 […] to multiply in the body, thus preventing hospitalization or death in patients with Covid-19 “. The EMA will assess the compliance of molnupiravir with the usual European standards for efficacy, safety and quality. authorization is also under evaluation by the United States Drugs Agency (FDA).
For its part, the company plans to manufacture the doses needed for 10 million treatments by the end of the year 2021. However, a large part of it risking returning to rich countries, as was the case for the vaccines, the Bill and Melinda Gates Foundation announced last week an investment of up to $ 120 million (about 103 million euros) to facilitate poor countries’ access to this treatment with tablets. Indeed, the United States has already planned to buy 1.7 million if molnupiravir was approved by the FDA.
If approved, molnupiravir would represent a major breakthrough that would easily and widely reduce severe forms of Covid-19. Indeed, if approved, it would become the first oral drug against SARS-CoV-2, and therefore would be easier to use. According to a clinical trial conducted by Merck on 775 patients with Covid-19, the treatment, given to patients within a few days of a positive test, halves the risk of hospitalization and death. If the results announced by Merck are confirmed, molnupiravir would be used to manufacture the first pill to treat Covid-19. Indeed, the anti-Covid treatments available today are administered by intravenous only. This step, if successful, would pave the way for a possible application for authorization of the Merck pill in the European Union.
Upon the announcement of the results by Merck, Anthony Fauci, immunologist and advisor to the White House, considered that the data from the clinical trial were “impressive”. Nathalie Dean, biostatistician specializing in infectious diseases at Emory University, explained to AFP after these results: “We can have treatments that are also effective, but if one is much easier to use than others, then its impact on the population will be greater. “
As a reminder, if approved, this drug would complement vaccines, and not replace them. Thus, professor at the University of Medicine of Houston (Texas) Peter Hotez recalled on twitter the 1er October, when Merck announced its results: “It is not a miracle drug, but a tool to support the vaccination. “
4/5 this is no substitute for vaccination. Its not a miracle cure but a companion tool. So get vaccinated. Another issue is emerging drug resistance. If this is used indiscriminately this can be a problem with antiviral drugs
– Prof Peter Hotez MD PhD (@PeterHotez) October 1, 2021
Molnupiravir is an investigational broad-spectrum antiviral. Initially intended to treat influenza and hepatitis C3, it is now envisaged as a means of combating various coronavirus, including the SARS-CoV-2 virus. The Merck laboratory wants to make a drug that reduces the risk of developing a severe form of Covid-19 disease.
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