Logo

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

Share this

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

Ref: BusinessWire | Image: Merck


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions