Covid: negative opinion of the French National Health Authority for molnupiravir, Merck’s antiviral treatment

Posted on December 10, 2019 2021 at 22:16Updated on Dec 10, 2019 2021 at 11:47 pm

The French High Health Authority (HAS) gave the green light on Friday for the use of AstraZeneca’s antiviral treatment, for patients at very high risk of suffering from the severe form of Covid-19.

The Evusheld treatment is a combination of monoclonal antibodies directed against the SARS-CoV-2 Spike protein, preventing it from entering and multiplying in human cells. It is administered intramuscularly and its effectiveness is obtained 14 days after its administration, during which the patient is not yet protected.

However, HAS did not authorize early access to molnupiravir, whose brand name is Lagevrio. Merck, which developed this treatment, requested their early access to “treatment of mild to moderate forms of Covid-19 in adults with a positive diagnostic test for SARS-CoV-2 and who have at least one risk factor for developing a disease. severe form of disease “. the illness “.

The Ministry of Health “takes note”

Based on an opinion of the National Agency for Drug Safety, which ruled that “the efficacy and safety of this drug was presumed in a restricted indication with respect to that alleged by the laboratory,” the HAS considered that Lagevrio did not meet the criteria necessary to obtain this authorization.

In a statement, the Health Ministry, which announced in late October that it had pre-ordered 50,000 doses of the treatment, said it took note of this decision. “The nature of the contract foresees that orders are activated only in the event of advance authorization for deployment. Discussions with the European Medicines Agency (EMA) are continuing and a European decision on the marketing authorization application is expected in early 2022, ”it is written.

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