European regulators recommend rejection of Merck’s Covid-19 drug molnupiravir
European regulators recommended the EMA reject Merck’s Covid antiviral, saying that there’s not enough evidence it works in patients.
Merck and partner Ridgeback Biotherapeutics announced the CHMP’s decision on Friday.
The committee refused to recommend the approval of Lagevrio, also known as molnupiravir, by initially stating that the review has been ongoing for more than a year. The committee had supported decisions from member states starting in November 2021, if they wanted to consider early use of molnupiravir before any potential approval.
Since then, the committee said that molnupiravir’s clinical benefit in adults with Covid-19 who are not on supplemental oxygen and at increased risk of developing severe Covid-19 “could not be demonstrated.” The CHMP said Merck submitted results of a study investigating the antiviral in more than 1,400 non-hospitalized and unvaccinated adults with “at least one underlying condition putting them at risk of severe Covid-19.”
Based on the totality of data, it was not possible to conclude that Lagevrio can reduce the risk of hospitalisation or death or shorten the duration of illness or time to recovery in adults at risk of severe disease. Furthermore, it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.
In a statement to Endpoints News, Merck said it believes “the CHMP’s recommendation does not reflect the compelling data” from its Phase III MOVe-OUT trial, the one that Merck used to obtain FDA emergency use authorization back in 2021. Merck added that it and Ridgeback are going to appeal the decision and request a re-examination of the CHMP’s opinion.
This is the newest twist for molnupiravir after the FDA axed the requirement that patients test positive for Covid-19 in order to be prescribed either Lagevrio or Paxlovid earlier this month. The FDA has not been Lagevrio’s biggest supporter, after an FDA adcomm voted 13-10 to approve emergency authorization in 2021, despite concerns of the drug’s mechanism of action — and only showing 30% effectiveness in preventing hospitalizations and deaths, down from 50% in an interim analysis.
FDA also said last summer that it would not allow Lagevrio to be prescribed by state-licensed pharmacists — even while allowing those same pharmacists to prescribe Paxlovid.
Despite the recommendation for Lagevrio, the committee posted a handful of positive decisions from its monthly meeting this week. Those include Incyte’s non-segmental vitiligo treatment Opzelura and an extension for Regeneron’s Libtayo — this time comboed with chemotherapy for PD-L1 positive NSCLC. Another positive recommendation went to Italian pharma Chiesi and partner Protalix BioTherapeutics’ candidate PRX-102, also known as Elfabrio, to treat Fabry disease.