Prices, risks, data: these questions posed by Merck’s anti-Covid pill

Soon, a simple pill to treat Covid? After the publication in early October of the press release from Merck-MSD, the American company which develops molnupiravir, the enthusiasm was immense. In fact, the first results obtained with this antiviral seem impressive: the drug “reduces the risk of hospitalization or death by about 50%”, says the company. During the first part of the phase 3 clinical trial, no deaths were to be deplored in the group of patients treated, against eight in the placebo group. The patients all had mild to moderate symptoms of Covid upon inclusion, and were at risk of progressing to a severe form of the disease, according to information from Merck-MSD.

These results prompted the group to stop the trial early, in agreement with the Food and Drug Administration (FDA), to quickly request marketing authorization in the United States. For their part, officials of the European Medicines Agency have just indicated at a press conference their intention to start the continuous review of this treatment. A procedure which aims to accelerate the evaluation of a marketing authorization application when it is formally submitted by the laboratory.

“We need published data, not just a press release”

If Merck’s announcements have been favorably received by the scientific community, some call for some precautions. “We need published data, and not a simple press release. It is impossible to make a pharmacological analysis on the basis of what has been presented for the moment by the company”, laments Professor Mathieu Molimard , head of the medical pharmacology department at the Bordeaux University Hospital Center (CHU). To measure the actual effectiveness of the drug, it is indeed necessary to know the detailed characteristics of the patients included in each group: their age, their risk factors, their level of antibodies against Covid, etc. Nevertheless, the data monitoring and follow-up committee (DSMB), which analyzes the results obtained over the course of the study, judged that these were significant, and that it would not be ethical to continue the trial against placebo.

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But this decision will also have the consequence of limiting the information available at this stage on the safety of this product. “For this, it would have at least been necessary to include all the patients initially planned in the study. These data will arrive later, via pharmacovigilance”, notes Professor Molimard. In other words, it will be necessary to wait until the pills are marketed to have a more precise idea of ​​their possible side effects. However, scientists have already warned about the risks of molnupiravir, because it breaks down in the body into a molecule known for its mutagenic effect, in other words potentially capable of causing cancer. This point remains debated: “This effect was seen on a cellular model, disputed by the company. On such a short duration of treatment, the impact, if it exists, would be especially on reproduction and the fetus: in the precautions for use, women of childbearing age must therefore be on the pill while waiting to learn more “, nuance Professor Molimard.

Over $ 700 per patient

Without waiting for the marketing authorizations, the laboratory has already embarked on a large-scale production of its orange pill. But questions are emerging about the price at which it will be marketed. The US government placed a pre-order in June: the agreement covers a cost of $ 1.2 billion, for the delivery of doses to treat 1.7 million patients. Or 705 dollars (608 euros) per patient. A staggering price, which could well constitute a brake on the use of this product, and which should in any case give rise to some debate. Especially since, at the beginning of October, two researchers from Harvard in the United States, and from King’s college hospital in the United Kingdom, showed that this drug could be produced for around twenty dollars per patient. The company has nevertheless concluded agreements so that its drug can be produced at low cost by manufacturers of generics intended for low- and middle-income countries.

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At this stage, however, molnupiravir does not appear to be able to compete with vaccines, which are much less expensive and much more protective against severe forms of Covid. It will be useful in addition to injections, for infected people who have not been immunized, or those in whom the vaccines do not work. Taken orally, it is indeed easier to administer than the monoclonal antibodies currently on the market, given intravenously. In the medium term, it could also provide a response in the event of the rapid dissemination of a new variant that bypasses the immunity conferred by vaccines. Faced with a virus as formidable as Sars-cov-2, all weapons are good to take.



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