FDA approves Zinplava to reduce Clostridium difficile infection recurrence
Merck announced that the FDA has approved Zinplava for the prevention of recurrent Clostridium difficile infection, or CDI, in adult patients.
Zinplava (bezlotoxumab, Merck) is indicated for use in patients aged 18 years or older who are receiving antibacterial drug treatment and are at a high risk for CDI recurrence. It does not treat CDI.
The fully human IgG1 monoclonal antibody works by neutralizing C. difficile toxin B.
In July, the FDA delayed an approval decision on bezlotoxumab by 3 months and requested that Merck submit new data and analyses from the MODIFY I and II clinical trials proving the drug’s efficacy.
A post hoc analysis of the global phase 3 trials by researchers in Europe showed that recurrence of CDI in patients given bezlotoxumab was 15% compared with 24.2% in those given placebo.
“For generations, Merck has been steadfast in its commitment to fighting infectious diseases — and that commitment continues today,” Nicholas Kartsonis, MD, vice president of clinical development, infectious diseases, Merck Research Laboratories, said in a news release.
Merck said it anticipates Zinplava being available in the first quarter of 2017.
Disclosure: Kartsonis works for Merck.