Marketing of molnupiravir: The European regulator will decide within “a few weeks”

By Manon C., Laurent P. Updated November 24, 2021 at 9:59 am Published November 24, 2021 at 9:05 am

Good news in the fight against Covid! The European Medicines Agency, which announced on November 19 that it had authorized the use, in cases of force majeure, of molnupiravir (Lagevrio), declared that it would decide on its marketing within “a few weeks”.

the molnupiravir, a anti-Covid pill effective against the virus? On November 19, the European regulator announced in a press release authorizing themolnupiravir use (marketed under the name of Lagevrio) in an emergency to avoid hospitalizations and worsening of Covid cases. An authorization which was valid only for a usage urgent, but in no case for a marketing. “Official authorization from the European Agency is expected within two months. But France can, for emergency or critical treatments, have early access“, then explained Clarisse Lhoste, patron of MSD France, the subsidiary of the American laboratory in France.

This Wednesday, November 24,European Medicines Agency announced that she would decide in a few weeks on a request for authorization from placing on the European market du molnupiravir. “The EMA will assess the benefits and risks of Lagevrio within a short timeframe and may issue an opinion in a few weeks if the data submitted is strong and complete enough to show the efficacy, safety and quality of the drug. ‘EMA concludes that Lagevrio’s benefits outweigh its risks in treating COVID 19, it will recommend (to the European Commission) for marketing authorization. “ the European regulator said in a statement.

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As a reminder, last March, the Merck laboratory and the pharmaceutical company Ridgeback Bio indicated in a press release that the drug, taken by oral, would reduce, or even eliminate, the viral load of coronavirus only a few days. “Knowing that there is an unmet need for antiviral treatments for SARS-CoV-2, we are encouraged by these preliminary results.“, thus explained Wendy Painter, researcher at Ridgeback Biotherapeutics. A study published from the journal American Society for Microbiology.

Regarding the preliminary results of this study, presented at the International Conference on Retroviruses and Opportunistic Infections (CROI), which took place from March 6 to 10, these were rather clear: out of the 202 outpatients in this phase 2 of the clinical trial, all saw “a faster decrease in viral load“after five days, as indicated William Fischer, professor of medicine at the University of North Carolina and one of the directors of this study.

And to continue: “If reinforced by additional studies, they could have significant public health consequences, as the virus continues to spread and evolve around the world.“. Phase 3 of the clinical trials is now complete, with more than conclusive results (with a 7.3% hospitalization or death rate, compared to 14.1% in those who had a placebo). THE‘company announced on October 11 request a marketing authorization for treatment, which would then be the first to treat the Covid-19, to the FDA, the Food & Drug Administration, in the United States.

The extreme consequences of this pandemic demand that we act with unprecedented urgency, and that is what our teams have done by submitting this molnupiravir (authorization) request to the FDA.“, explained Robert Davis, CEO of Merck, in a press release. And to specify work”actively with regulatory agencies around the world to submit emergency use or marketing authorization requests in the coming months“.

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To note that Merck & Co is also working on a treatment for Covid, the MK-711, and whose clinical trials are just as promising since the researchers noted at the end of January, in a press release, a decrease in 50% risk of death or respiratory failure in the hospitalized patients included in this trial. It is also recalled that the American laboratory announced several weeks ago to end its clinical trials on the development of two vaccines, the results of which were inconclusive.