Merck’s V114 Receives FDA’s Breakthrough Therapy Designation to Prevent Invasive Pneumococcal Disease

Merck’s V114 Receives FDA’s Breakthrough Therapy Designation to Prevent Invasive Pneumococcal Disease

Shots:

  • The BT designation is based on P-I/II and P-II results assessing four lots of V114 in healthy adults and infants, demonstrating non-inferiority data in patients
  • FDA’s BT designation is granted to the drugs showing clinical improvement over a currently available therapy on at least one clinically significant endpoint with benefits of Priority Review and Accelerated Approval
  • V114 is a 15-valent pneumococcal conjugate vaccine targeted for two disease-causing serotypes (22F and 33F), evaluated in P-III for the prevention of IPD in adults

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