Posted by Michael Wonder on 24 Oct 2016
FDA approves Merck’s Zinplava (bezlotoxumab) to reduce recurrence of Clostridium difficile Infection (CDI) in adult patients receiving antibacterial drug treatment for CDI who are at high risk of CDI recurrence
24 October 2016 - Merck today announced that the U.S. FDA has approved Zinplava (bezlotoxumab) 25 mg/mL solution for injection.
Merck anticipates making Zinplava available in first quarter 2017.
Zinplava is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. Zinplava is not indicated for the treatment of CDI. Zinplava is not an antibacterial drug. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI.
CDI is caused by bacteria that produce toxins, including toxin B. Symptoms of CDI include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent CDI is higher in certain patient populations, including people 65 years of age or older and those with compromised immune systems.
