Posted by Michael Wonder on 23 Nov 2016
CHMP adopts positive opinion for Zinplava
23 November 2016 - Bezlotoxumab is a human monoclonal anti-toxin antibody that binds with high affinity to Clostridium difficile toxin B and neutralises its activity.
On 22 November 2016, the CHMP adopted a positive opinion via written procedure, recommending the granting of a marketing authorisation for Zinplava, intended for the prevention of recurrence of Clostridium difficile infection.
The full indication is: "Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection in adults at high risk for recurrence of Clostridium difficile infection."
