Commercialization of Molnupiravir: the European regulator to decide within a "few weeks"

Published by Manon C., Laurent P. · Updated on 24 November 2021 at 09h59 · Published on 24 November 2021 at 09h05
Good news amid the fight against Covid! This Friday November 19, 2021, the European Medicines Agency announced they have approved the emergency use of molnupiravir (Lafevrio), and said they will decide on commercialization within a "few weeks".

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.

This Wednesday November 24, the European Medicines Agency said they will decide within a few weeks on the seek for approval of commercialization in the EU of molnupiravir. "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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