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