Zinplava drug of Merck has been approved by FDA

The FDA clarified the efficacy of Merck's Clostridium difficile (CDI) relapse drug Zinplava after a three-month extension of the review period. Merck said it expects Zinplava to be available in the first quarter of next year.

Through research using recombinant human proteins, patients with Zinplava (17.4% and 15.7%) or Zinplava and actoxumab (15.9% and 14.9%) had a significantly lower recurrence rate at week 12 than patients taking placebo (27.6%) in a phase III study of Pivotal (25.7%). Thus, Zinplava (bezlotoxumab) is thought to reduce the recurrence of CDI in patients aged 18 years or older who have received antimicrobial therapy and have a high risk of recurrence.

The company emphasizes that its drug is not an antibacterial agent, and therefore it can't be used in the actual treatment of infection. But rather a monoclonal antibody for neutralizing Clostridium difficile toxin B, which may damage the intestinal wall and cause inflammation, leading to diarrhea.

At the same time, about a quarter of patients have a recurrence after the first episode, and more than 40% of patients have a recurrence, indicating a need to continue looking for new ways to break the cycle of infection.

According to the US Centers for Disease Control and Prevention, the data show that only in the year of 2011, Clostridium difficile caused nearly 500,000 cases of infection in the United States, of which 29,000 people died within 30 days after the initial diagnosis. Flarebio offers recombinant proteins of good quality like recombinant Cdh9 at competitive prices.