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

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

Click Here to read full press release/ article | Ref: BusinessWire | Image: Indolink English

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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