Merck will appeal EU rejection of COVID drug Lagevrio

 Merck & Co has said it will ask the EMA’s human medicines committee (CHMP) to look again at a decision not to recommend approval of its antiviral Lagevrio for treating some people with COVID-19.

Along with development partner Ridgeback Therapeutics, the US pharma group has said that it will appeal the decision and request a re-examination of the CHMP’s opinion, as it “does not reflect the compelling data” for the drug.

The EMA started a regulatory review of Lagevrio back in November 2021, shortly after the drug was approved for marketing in the UK as a treatment for people with mild to moderate COVID-19 who are at increased risk of developing severe disease.

At the time, oral antivirals like Lagevrio and Pfizer’s Paxlovid (nirmatrelvir/ritonavir) were being hailed as a key weapon in the fight against COVID-19, as they could be delivered to patients outside hospital - unlike therapies such as Gilead Sciences’ intravenously-administered antiviral Veklury (remdesivir).

Merck applied for approval of Lagevrio in the EU on the back of data from the MOVe-OUT trial, which showed a significant 50% reduced risk of hospitalisation or death compared to placebo, cutting the rate to 7% from 14% in adults with COVID-19 who are not receiving supplemental oxygen and who are at increased risk of developing severe COVID-19.

Other studies have not backed up that efficacy signal, however. Last year, the 25,000-subject PANORAMIC trial compared Lagevrio (molnupiravir) to placebo in people at risk of severe COVID showed that Lagevrio hastened the time to recovery from COVID-19 by around six days, but was no better than placebo at keeping patients out of hospital: the primary objective of the trial.

In its recommendation, the CHMP has said that, based on the totality of data, it was not possible to say 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.”

It also said it was not possible to identify a group of patients who might benefit from the drug.

In its fourth-quarter results update, Merck projected sales of Lagevrio will be around $1 billion this year, down from a peak of nearly $5.7 billion last year.

“Data generated from the […] MOVe-OUT trial and from real-world studies demonstrate 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,” said Merck’s head of R&D, Dean Li.

He added that more than four million patients worldwide have been treated with Lagevrio, which is authorised for use in more than 25 countries worldwide.

The benefit of Lagevrio has, however, also been called into question by health technology assessment (HTA) agencies, including NICE in the UK and ICER in the US, which have both concluded the drug’s benefits do not outweigh its cost.

https://pharmaphorum.com/news/merck-will-appeal-eu-rejection-covid-drug-lagevrio