MOLNUPIRAVIR. The European Medicines Agency has authorized the use of anti-Covid tablets from the American laboratory Merck. Under what conditions? The answers.
[Mis à jour le 19 novembre 2021 à 20h04] On Friday, November 19, the European Medicines Agency (EMA) said it had “issued recommendations” for the use, in case of emergency, of molnupiravir. “The EMA has issued this opinion to support national authorities who can decide on a possible early use of the drug before the marketing authorization, for example in emergency situations,” said a statement. This experimental antiviral was developed by the American laboratory Merck in the form of anti-Covid pills, before they were formally authorized on the Old Continent. In the same statement, the EMA also clarified that member states could therefore now use it “to treat adults with Covid-19 who do not need additional oxygen and who are at increased risk of developing an severe form “of coronavirus.
Separately, the European regulator announced that it was reviewing Pfizer tablets for a similar reason. These two treatments, developed by behemoths in the American pharmaceutical sector, would reduce the risk of hospitalization and death in so-called “at risk” patients, according to several studies. Also, the use of this tablet would make it possible to arm ourselves in the face of a new wave while “increasing rates of infection and death due to Covid-19” are currently observed in Europe. On the other hand, it is not recommended for pregnant women or women not using contraception and who could become pregnant, to use this pill of molnupiravir.
On October 25, the European Medicines Agency (EMA) announced the launch of the accelerated review of molnupiravir, the oral antiviral drug against Covid-19, developed by the American laboratory Merck. According to clinical trial results published on October 1, the treatment would reduce “mortality and the need for hospitalization (-50%)” in patients who test positive for the coronavirus, when it is administered less than five days after the onset of symptoms. These “promising results”, hailed by the Scientific Council, do they mean that molnupiravir could eventually replace the anti-Covid vaccine?
Mathieu Molimard, professor of pharmacology and president of CHU Pellegrin, calls for caution. “This study was done with about 400 patients treated, it was stopped halfway because the results were satisfactory. These 50% [d’hospitalisations et de décès en moins], we must reduce them in absolute value, we avoid about 25 hospitalizations for 400 patients treated. That’s good, but it’s not the revolution either “, he explained on Franceinfo, estimating that molnupiravir alone “will probably not be enough”: “You need several drugs, often in combination.”
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 is likely to return to the 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. 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.
According to a clinical trial conducted by Merck on 775 Covid-19 patients, the treatment, given to patients in the days following a positive test, halves the risks of hospitalization and death. According to the laboratory, the hospitalization rate was 7.3% in the group that received the treatment, versus 14.1% in the group that did not receive it. There were also no deaths in the treated group, while the untreated group deplored eight deaths. If the results announced by Merck are confirmed, molnupiravir would be used to manufacture the first pill to treat Covid-19, which should be taken very quickly after the discovery of positive coronavirus.
In his interview with FranceInfo, Professor Mathieu Molimard specified the modalities of taking the drug: “50,000 doses, 10 doses are needed to make a treatment, that makes 5,000 patients”. He insisted on the public concerned with Merck’s anti-Covid drug: “This will be usable for patients who do not respond to vaccines, who are on immunosuppressants and who have a high chance of going to the hospital. is not for everyone. “
As soon as the results were announced by Merck, Anthony Fauci, immunologist and adviser 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 1is 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
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Molnupiravir, also referred to as “MK-4482” or “Lagevrio”, is an investigational broad spectrum antiviral. Initially intended to treat influenza and hepatitis C3, it is now envisaged as a means of combating various coronaviruses, 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. Indeed, having the capacity to be incorporated into the genome of the coronavirus, it causes errors in the replication of the virus’s RNA, preventing it from spreading.
However, if it were authorized, Merck’s drug would not be a miracle cure, as Professor Mathieu Molimard said at the microphone of FranceInfo: “It’s better to have an oral form like molnupiravir, but a antiviral will probably not be enough. We have effective treatments when we act at several levels of reproduction of the virus. The virus is not a bacterium, it enters our cells, and to block it, if we act too hard, we kill our cells, so you have to block it in several places. You need several drugs, often in combination. “
However, there are some concerns about molnupiravir. Because of its mechanism of action (modify the genome of the virus), it could be mutagenic for humans: being able to be incorporated into the RNA of the virus, it can, in theory, perhaps penetrate into the RNA human and create a mutation, which could generate cancerous tumors. However, the Merck laboratory claimed to have studied this potential problem and was very optimistic about the additional results of the studies that will assess this risk.
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