Merck gains Breakthrough Therapy designation for V114
US pharma giant Merck & Co (NYSE: MRK) says its investigational 15-valent pneumococcal conjugate vaccine,V114, has received Breakthrough Therapy designation from the US Food and Drug Administration for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients six 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 III clinical trials.
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.
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