Coronavirus: the Haute Autorité de Santé does not approve emergency marketing of molnupiravir

Published by Laurent P., Manon C. · Published on 13 December 2021 at 14h17
The Haute Autorité de Santé announced - in a report issued on December 10 - they do not approve the emergency use of molnupiravir (Lafevrio) to prevent coronavirus infection. The issue goes against what the European Medicines Agency announced this past November 19, namely approving the emergency use of the drug in case of emergency.

Is molnupiravir an effective Covid therapy? The application has been mostly approved since this Friday November 19, the European regulator issued a release approving the emergency use of molnupiravir to prevent hospitalizations and deterioration of Covid cases. The approval only applies to emergency use and not for marketing. It is necessary to wait for the EMA to release a definitive report on the matter. "We wait for about two months for the official approval of the European Agency. But France can - for emergency use - get an early access", Clarisse Lhoste, CEO of the French subsidiary of the American laboratory MSD France explains.

But this early access might not be enjoyed in France... And for good reason, this Friday December 10, in a public release, the Haute Autorité de Santé announced they are not approving the emergency use of the therapy developed by the Merck laboratories. Why? Because of the limited effectiveness, below the therapy already marketed and below what was announced by the American laboratory: "the effectiveness results delivered by the laboratory are less effective than those from the available therapies: 30% reduction of risks of progress to severe Covid-19 (...) while the effectiveness of the casirivimab-imdevimab monoclonal antibodies reaches about 80% on the same criteria", the HAS explains.

This same Friday, the Health Minister claimed they "duly record" the release, adding orders and administration of the therapy will be conditioned to the approval of the Haute Autorité de Santé. "Exchanges with the European Medicines Agency (EMA) continue and a European agreement as for the seek for approval for marketing is expected as early as the beginning of 2022", the minister explains in a release.

France is then waiting for total approval from the European regulator. And if approved, it will be granted in a few weeks, as the European Medicines Agency explained this past November 24. "EMA will assess the benefits and risks of Lagevrio under a reduced timeline and could issue an opinion within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the medicine. If EMA concludes that the benefits of Lagevrio outweigh its risks in treating COVID‑19, it will recommend granting a marketing authorization", the European regulator stated in a release.

For the record, this past March, drugmaker Merck and pharmaceutical company Ridgeback Bio, reported in a release the medication – given orally – can reduce and even delete coronavirus viral load in a matter of days. “At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data”, Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics explains. The study has been released in the American Society for Microbiology since then.

As for these preliminary data - presented during the Conference on Retroviruses and Opportunistic Infections (CROI) that took place from March 6 to 10, 2021 - they are rather clear: in 202 non-hospitalized patients included in the 2a phase of the clinical trials, they have all seen “quicker decrease in infectious virus” in five days, lead investigator of the study and University of North Carolina Professor of Medicine Dr. William Fischer explains.

He goes on: “if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally”. As the clinical trial phase 3 is now over, leading to highly encouraging results (with an hospitalization or death rate of 7.3% against 14.1% in those given a placebo), and the company announced this Monday October 11, they are seeking FDA marketing approval for emergency use, for this therapy that could be the first one to cure Covid-19

"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data", Merck CEO and President Robert Davis said in the statement. He added they are "actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months".

Note Merck is also working on Covid cure, MK-711, and which clinical trials are just as promising since back to late January, searchers stated in a release they noticed a 50% decrease in death risk and breathing failure in hospitalized patients included in the trial. For the record, the German laboratory also announced several weeks ago they were stopping clinical trials on two vaccines as preliminary data were not conclusive.

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