NETHERLANDS — Merck and Ridgeback Biotherapeutics’ COVID-19 pill Lagevrio has been recommended against approval by a key committee of the European Medicines Agency (EMA).

The committee concluded that a clinical benefit for at-risk infected adults “could not be demonstrated” based on data from the Phase 3 MOVe-OUT trial and other studies submitted by Merck.

The companies plan to appeal the decision and request a re-examination of the negative opinion. Despite the EMA’s decision, Lagevrio remains available in 16 EU countries as it was supported by the agency’s advice in 2021 for its use before an EU-wide authorization.

The negative decision contrasts with approvals of Lagevrio in 25 countries including the US, UK, Japan, and China.

This is the second setback for Merck as the drugmaker also announced that the pill failed to reduce the risk of getting COVID in a large clinical trial.

Merck’s recent setback with Lagevrio follows a similar trend seen with Pfizer’s antiviral pill, Paxlovid, which also failed to prevent the spread of the virus within households.

Consequently, Merck has adjusted its sales projections for Lagevrio, expecting a decrease from US$5.7 billion in 2022 to US$1 billion in 2023.

However, Merck is exploring other potential uses for the drug, including as a treatment for respiratory syncytial virus (RSV), and has initiated a study in that direction.

Other companies, including AstraZeneca, Sanofi, and Pfizer, are also pursuing RSV treatments and awaiting FDA decisions.

Pfizer is partnering with ReViral to advance an RSV treatment and could report preliminary trial data in late 2023.

Meanwhile, Merck has announced that it will appeal the recommendation made by the EU’s CHMP to reject its COVID-19 antiviral, Lagevrio.

Despite receiving authorization in over 25 countries, including the US and the UK, the CHMP claimed that there was a lack of evidence to support the drug’s efficacy.

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.

Merck highlighted data from a trial of 1,400 unvaccinated adults as “compelling evidence” of the drug’s positive impact on reducing hospitalization and death rates among those at risk of severe disease.

However, the CHMP remained unconvinced, stating that “the clinical benefit of Lagevrio could not be demonstrated” and that “it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.”

Despite this, Merck remains confident that Lagevrio has an important role to play in the COVID-19 treatment landscape.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.