Merck to appeal EU rejection of COVID-19 drug
Life sciences giant Merck & Co has announced that it will appeal the EU’s Committee for Medicinal Products for Human Use’s (CHMP) decision to not recommend approval for its COVID-19 drug Lagevrio.
Both Merck and its development partner Ridgeback Therapeutics have promised they will request a re-examination, as they believe CHMP’s decision “does not reflect the compelling data” for the drug.
The EMA started a review of Lagevrio in November 2021 shortly after the drug was approved for the UK market as a treatment for people with mild to moderate COVID-19 who are at an increased risk of developing severe disease. The review was based on data from the MOVe-OUT trial, which showed a 50% reduced risk of hospitalisation or death compared to placebo ‒ cutting the rate from 14% to 7% in adults with COVID-19 who are not receiving supplemental oxygen and who are at an increased risk of developing COVID-19.
In 2022 however, the 25,000 patient-strong PANORAMIC trial compared Lagevrio to placebo and found that, while people recovered around six days faster with Lagevrio, it was no better at keeping patients from having to be hospitalised.
In its recommendation, CHMP stated that the totality of the data meant it was not possible to say if 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.”
In answer, Merck’s head of R&D, Dean Li stated: “Data generated from the […] MOVe-OUT trial and from real-world studies demonstrates 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.”