Zinplava®, un anticorps monoclonal contre C. difficile

Autorisation européenne de mise sur le marché pour cet anticorps monoclonal efficace dans la prévention de la récurrence des infections par Clostridium difficile chez les adultes à haut risque de réinfection. Suite à deux études multicentriques, randomisées contre placebo, en double aveugle.

“The benefits with Zinplava are its ability to prevent the recurrence of C. difficile infection diarrhoea episodes in the 12 weeks after treatment. The most common side effects following infusion are nausea, pyrexia and headache.

The full indication is: Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

www.ema.europa.eu/ema/