Merck & Co. (MRK) is officially done with Zinplava in Europe. The company is permanently discontinuing the bacterial infection therapy, also known as bezlotoxumab, for commercial reasons.
Merck Pulls Bacterial Infection Drug Zinplava From Europe After US Exit
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Europe Says Goodbye
After 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.
Zinplava had been on the European market since regulators granted it a five-year marketing authorization on January 18, 2017. The drug was cleared 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 later granted the treatment unlimited validity in 2021, then extended its indication to include pediatric patients aged one and older in December 2023.
The US Already Moved On
The European regulatory withdrawal lines up 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 market data.
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