Nestlé Health Science and IdB Holding have officially announced a VOWST licensing agreement to develop and commercialize the oral therapy in Europe, subject to approval by the European Medicines Agency (EMA). This collaboration aims to expand European patient access to therapies preventing recurrent Clostridioides difficile infection, a severe gastrointestinal condition with limited management options.
Currently approved exclusively in the United States by the FDA, VOWST (fecal microbiota spores, live–brpk) is a first-in-class, orally administered live biotherapeutic product. It is indicated for the prevention of recurrent Clostridioides difficile infection in individuals 18 years of age and older following antibacterial treatment.
Under the newly formed VOWST licensing agreement, the two organizations will collaborate on clinical and regulatory activities to pursue EMA approval. Upon successful authorization, IdB Holding will secure the rights to commercialize the drug across European markets.
To support this market entry, the Italian life sciences group plans to launch a new, dedicated company focused on the European marketing of the live biotherapeutic product and other therapies targeting high unmet medical needs.
Luis Briz, President of Professional Health at Nestlé Health Science, noted that the partnership represents a meaningful step toward bringing this preventive therapy to European patients, reflecting confidence in the drug’s clinical foundation. Similarly, Gianluigi Frozzi, President of IdB Holding, stated that the milestone signifies mutual trust and the exchange of expertise, opening a new chapter for the organization.
The target indication involves a gastrointestinal infection linked to microbiome dysbiosis, which carries substantial morbidity and mortality risks. While the therapy is utilized to prevent recurrence after antibiotic treatment, it is not intended as a direct treatment for the active infection itself.
Because the formulation contains live bacteria, it should not be administered concurrently with antibiotics, as antibacterial drugs can interfere with its efficacy. Common side effects reported in clinical profiles include abdominal bloating, fatigue, constipation, chills, and diarrhea.
