Merck, Ridgeback Withdraw COVID-19 Pill European Application Amid Regulatory Hurdles

Merck & Co Inc MRK and Ridgeback Biotherapeutics have reportedly withdrawn their COVID-19 pill application in the European Union (EU).

The withdrawal came after the European Medicines Agency cited insufficient data for not backing the drug.

Merck had asked the regulator's Committee for Medicinal Products for Human Use (CHMP) to re-examine the application for molnupiravir, sold under the brand Lagevrio in several countries.

The CHMP had advised against the market authorization of the drug in February.

Citing the agency, Reuters stated the drug could not demonstrate benefits for COVID patients who did not require oxygen support and were at risk of their disease worsening.

Related: Merck's COVID-19 Treatment Fails To Prevent Infection In Household Exposure.

The pill's effectiveness, at only 30%, has also been overshadowed by Pfizer Inc.'s PFE COVID drug, Paxlovid, which has nearly 90% effectiveness.

"We are evaluating our options on how we can generate additional evidence supportive of Lagevrio for the treatment of COVID-19," said Dean Li, Merck's research head.

Merck expressed commitment to continue providing Lagevrio through "compassionate or emergency use programs" authorized by individual EU member states.

For FY23, Merck expects a significant decline in sales of Lagevrio (COVID-19 treatment), which are expected to be approximately $1.0 billion, down from $5.7 billion in 2022.

MRK Price Action: Merck shares are up 0.12% at $113.20 on the last check Tuesday.