FDA Approves Clostridium Difficile Infection Drug

The FDA has approved Zinplava (bezlotoxumab) in a 25-mg/mL injectable form to be available in 2017.

Zinplava is indicated to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving an antibacterial drug treatment of CDI and also happen to be at high risk of CDI recurrence. However, Zinplava is not indicated to treat CDI, and it is not an antibacterial drug. It should only be used in conjunction with antibacterial treatment of CDI.

“For generations, Merck has been steadfast in its commitment to fighting infectious diseases―and that commitment continues today,” said Dr. Nicholas Kartsonis, vice president of clinical development of infectious diseases at Merck Research Laboratories. “Zinplava is a human monoclonal antibody that binds to C difficiletoxin B and neutralizes its effects.”

The most common adverse effects seen in patients who received Zinplava in clinical trials were nausea, pyrexia, and headache. However, heart failure was also reported in 2 phase 3 clinical trials in patients who received the drug compared to a placebo. It typically occurred in patients who had a history of congestive heart failure (CHF) or underlying CHF.

Some infusion-related reactions were documented in trial patients, as well. These effects included nausea, fatigue, headache, dizziness, pyrexia, dyspnea, and hypertension. Among the individuals who experienced these reactions, 78% of the reactions were mild.