The Committee for Medicinal Products for Human Use (CHMP) the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion via written procedure, recommending the granting of a marketing authorisation for the medicinal product Merck Sharp & Dohme's Zinplava, intended for the prevention of recurrence of Clostridium difficile infection (CDI).
Zinplava will be available as a 25 mg/ml concentrate for solution for infusion. The active substance of Zinplava is bezlotoxumab, a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity (ATC code: J06BB21).
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.
"Zinplava is indicated for the prevention of recurrence ofClostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1).”
According to EMA release, 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.