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Merck Receives FDA Breakthrough Therapy Designation For V114 - Quick Facts

Merck & Co. Inc. (MRK), said Wednesday that V114, the company's investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease or 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, according to Merck.

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

Merck noted that 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.

Merck said that 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.

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