Therapy Areas: Vaccines
US Merck Receives Breakthrough Therapy Designation from FDA for V114, Its Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents
31 January 2019 - - V114, US-based pharmaceutical company Merck's (NYSE: MRK) investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the US Food and Drug Administration for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age, the company said.

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 programme, access to a scientific liaison to help accelerate review time and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

According to Merck, FDA's decision was informed in part by immunogenicity data from two studies. Study 005 was a Phase 1/2, multicentre, randomised, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of four 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.
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