European Authority Recommends Against Approval For Merck-Ridgeback Biotherapeutics' COVID-19 Pill

Merck & Co Inc MRK and Ridgeback Biotherapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the refusal of the marketing authorization for Lagevrio (molnupiravir) for COVID-19 treatment in certain adults patients.
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP's opinion.
Related: Merck's COVID-19 Treatment Fails To Prevent Infection In Household Exposure.
"More than 4 million patients worldwide have been treated with Lagevrio. We remain confident that Lagevrio has an important role to play in the COVID‑19 treatment landscape and will appeal this opinion."
The company 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.
The EMA scientific opinion under Article 5(3) of Regulation (EC) 726/2004, which has supported the decision by 16 EU national authorities to make LAGEVRIO available, remains in effect.
Price Action: MRK shares closed at $110.36 on Thursday.