Merck Discontinues Bacterial Infection Drug in Europe

Merck & Co Inc. (NYSE:MRK) is permanently discontinuing its bacterial infection therapy Zinplava (bezlotoxumab) for commercial reasons.

European Regulators Revoke Marketing Authorization

Following a direct notification and request from marketing authorization holder Merck Sharp & Dohme B.V., the European Commission formally withdrew the medicine’s marketing authorization across the European Union on Tuesday.

European regulators initially granted Zinplava a five-year marketing authorization on January 18, 2017.

Regulators cleared the antibody drug to prevent the recurrence of Clostridium difficile infection (CDI) in high-risk adult patients.

CDI is a bacterial colon illness caused by the bacterium Clostridioides difficile, which leads to inflammation of the colon (colitis) and ranges from mild diarrhea to life-threatening damage.

The European Commission subsequently granted the treatment unlimited validity in 2021 before extending its indication to include pediatric patients aged one and older in December 2023.

Planned Commercial Exit In The United States

The European regulatory withdrawal aligns with an impending market exit in the United States. In December 2024, Merck discontinued the therapy in the U.S.

The FDA originally approved the antibody medication in 2016 to prevent recurrent CDI, targeting a dangerous bacterial condition that can trigger fatal diarrhea in patients.

MRK Price Action: Merck & Co shares were up 3.19% at $148.21 at the time of publication on Tuesday, according to Benzinga Pro data.

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