Drug Development

Merck completes a clinical trial Odyssey, finally bagging an FDA OK for C diff antibody

Nicholas Kartsonis, Merck

Nicholas Kartsonis, Merck

Merck had to endure delays and some scolding by experts along the way, but the pharma giant has picked up the FDA’s approval to start marketing bezlotoxumab to prevent the recurrence of Clostridium difficile infections. The drug will be sold as Zinplava, with a launch planned for early 2017.

Picked up from Medarex just months before the Bristol-Myers’ buyout, Merck $MRK believes that the IgG1/kappa antibody can help prevent tens of thousands of new cases of C. diff each year among high-risk patients.

Back in June, an FDA panel of outside experts voted 10 to 5 to approve the drug, with the 5 ‘no’ voters raising pointed concerns that Merck never made the pivotal study large enough to identify which patients would be most likely to benefit from it. That may have helped persuade the agency to hold back on an approval, pushing the PDUFA date back to October 23rd, when it finally flashed the green light after requesting some more info from Merck.

One of the reasons for the delays and debate over this treatment may have had to do with the fact that Merck had been developing the program in tandem with actoxumab. But the complementary therapy failed to measure up in a pivotal test of its own as a combo with bezlotoxumab, and the pharma giant flushed that drug last fall as it signaled plans to push ahead for a solo approval.

Merck’s team has had plenty of time with this program. The company in-licensed the treatment from Medarex and the University of Massachusetts Medical School back in 2009. While Zinplava is not an antibiotic, Merck has been investing heavily in the field, including its $9.5 billion buyout of Cubist.

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


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RAPS Regulatory Convergence 2017