Merck to Appeal EU Regulator’s Decision to Reject COVID-19 Drug
The antiviral of Merck’s key competitor, Pfizer’s Paxlovid, received full approval in January 2022. Now the company is fighting to catch up.

Merck will appeal the recommendation by the Europe Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) that the European Medicines Agency (EMA) rejects its COVID-19 antiviral, Lagevrio (molnupiravir).

The decision comes after months of deliberation by European regulators, who began looking at Lagevrio, in November 2021. The CHMP said there was a lack of evidence to support its efficacy in patients. There have also been previous concerns that the benefits of Merck’s drug do not outweigh its cost.

In its response to European regulators, Merck highlighted that more than 25 countries have authorized the use of the antiviral, including the US and the United Kingdom, which was the first country to authorize the drug in November 2021, the same month the CHMP started its review process.

Deaths from COVID-19 applied pressure on regulators to get Lagevrio and its competitor, Paxlovid (Pfizer), available as fast as possible.

But doubts about the side effects of the pill have been present from the start, and even countries that approve Lagevrio place restrictions on its use. The US Food and Drug Administration (FDA) advises that it should only be used “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.” It also cannot be given to patients under the age of 18, or to pregnant women due to the potential for birth defects.

“More than four million patients worldwide have been treated with Lagevrio,” Dr Dean Li, president of Merck Research Laboratories said. “We remain confident that Lagevrio has an important role to play in the COVID-10 treatment landscape.”

Merck provided the CHMP with data from a trial of 1,400 unvaccinated adults, which the company said provided “compelling evidence” from real-world use, and 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.”

But the CHMP was unimpressed, and its decision unambiguous: “The clinical benefit of Lagevrio could not be demonstrated.”

“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,” the agency said. “Furthermore, it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.”

Lagevrio made Merck over $5.7 billion in sales last year. Merck and its development partner Ridgeback Therapeutics said they expect to make around $1 billion from the antiviral in 2023.

Image Credits: Creative Commons.

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