FDA

Merck Sharp & Dohme 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) in pediatric patients 6 weeks to 18 years of age.

The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs intended for serious or life-threatening conditions.

The FDA decision comes on the back of data from two studies – study 005 and V114 which both showed an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine.

Dr. Nicholas Kartsonis, senior VP and head of vaccine and infectious diseases at Merck Research Laboratories said: “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

“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.”