the High Authority for Health refuses to grant authorization for early access to molnupiravir

It’s no. The High Authority for Health (HAS) refused to grant early access authorization to Lagevrio (molnupiravir), a treatment for Covid-19 developed speak laboratory MSD France and that the government had ordered, she announced in a notice released Friday, December 10.

If she assures that “Ldrug treatments “ have a role to play “especially for people who respond poorly or not to vaccination or who are not eligible”, it nevertheless considers that it is not efficient enough compared to what already exists. “The efficacy results put forward by the laboratory are less good than those of the available treatments: 30% reduction in the risk of progression to the severe form of Covid-19 (…) while the efficacy for monoclonal antibodies casirivimab-imdevimab is about 80% on this same criterion “.

However, the treatment was approved in the European Union for emergency use, before its formal marketing authorization. It is also in the process of being validated by the health authorities in the United States.

France had ordered 50,000 doses. The Ministry of Health reacted on Friday evening by saying “take note” of the decision of the HAS, and ensures that his order was conditional on the early authorization of the HAS. “Discussions with the European Medicines Agency (EMA) continue and a European decision concerning the marketing authorization application is expected at the beginning of 2022”, specifies the press release of the ministry.

HAS, on the other hand, authorized the use of Evusheld (tixagévimab-cilgavimab), from the AstraZeneca laboratory. The treatment is designed for patients aged 18 and over at very high risk of severe form of Covid-19 and who are poorly or not protected by vaccination and those who are not eligible for it. It is administered intramuscularly and its effectiveness is achieved 14 days after its administration. According to the results consulted by the HAS, the treatment reduces the incidence of cases of symptomatic infections by approximately 80% and provides a duration of protection of at least six months after the administration of a single dose.

Due to a cardiovascular risk identified during clinical trials, it is recommended not to administer Evusheld to people with at least two cardiovascular risk factors (dyslipidemia, diabetes, obesity, hypertension, smoking, advanced age, etc.).