The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorisation for Merck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir).
After evaluating the data provided by the companies, CHMP concluded that Lagevrio’s clinical benefit in the treatment of Covid-19 could not be demonstrated in adult subjects.
The direct-acting oral, broad-spectrum antiviral agent Lagevrio is intended to treat Covid-19 in certain adult patients.
Merck and Ridgeback intend to appeal the decision and request re-examination of the opinion of the regulator.
The scientific opinion of the EMA that has supported 16 EU national authorities’ decision for making Lagevrio available, remains in effect.
Merck Research Laboratories president Dr Dean Li said: “We believe the CHMP’s recommendation does not reflect the compelling data generated from the Phase III MOVe-OUT trial and from real-world studies demonstrating the positive impact that LAGEVRIO can provide for patients by reducing the risk of hospitalisation and death among adults at increased risk for severe disease.
“More than four million patients worldwide have been treated with Lagevrio. We remain confident that Lagevrio has an important role to play in the Covid‑19 treatment landscape and will appeal this opinion.”
Lagevrio has received approval or authorisation for use in over 25 countries, including China, the UK, Japan, the US, and Australia to treat certain Covid-19 adult patients.
It was assessed in the placebo-controlled, multi-site randomised, double-blind, global Phase III MOVe-OUT trial in non-hospitalised symptomatic, laboratory-confirmed mild to moderate Covid-19 adult patients.
Ridgeback Biotherapeutics CEO Wendy Holman said: “LAGEVRIO is prescribed globally as an important medicine for appropriate adult patients at risk for severe disease, and there is a critical need for multiple approaches to treat Covid-19.”
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