FDA Breakthrough Therapy Designation Received by Merck for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease

Merck, known as MSD outside of the United States and Canada, today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for the prevention of IPD in adults. Both indications are currently being studied in Phase 3 clinical trials.

The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs intended for serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. The benefits of this Breakthrough Therapy Designation include more intensive guidance from FDA on an efficient drug development program, access to a scientific liaison to help accelerate review time and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

The FDA’s decision was informed in part by immunogenicity data from two studies. Study 005 was a Phase 1/2, multicentre, randomized, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of 4 different lots of a new formulation of V114 in healthy adults and infants. Study 008 was a proof of concept, Phase 2, pediatric trial to confirm the results from Study 005 in a larger population of infants. In both studies, V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines.

“We are pleased with the data on V114 compiled to date, and we look forward to working closely with the FDA on the subsequent development of this investigational vaccine,” said Dr. Nicholas Kartsonis, senior vice president and head of vaccine and infectious diseases clinical research at Merck Research Laboratories. “The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”



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