Sanofi Reports FDA’s Acceptance of BLA for MenQuadfi to Prevent Meningococcal Meningitis

 Sanofi Reports FDA’s Acceptance of BLA for MenQuadfi to Prevent Meningococcal Meningitis

Sanofi Reports FDA’s Acceptance of BLA for MenQuadfi to Prevent Meningococcal Meningitis

Shots:

  • The FDA’s acceptance of BLA for review follows P-II & P-III study assessing MenQuadfi in patients aged ≥ 2yrs. conducted in the US
  • MenQuadfi is currently evaluated in P-II & P-III studies in the US, EU, Asia & Latin America with an additional P-III studies in Africa in patients ranging from infants 6 weeks of age to older adults
  • Sanofi’s MenQuadfi is a meningococcal (Groups A, C, Y, W) polysaccharide-tetanus toxoid conjugate vaccine with an ability to protect individuals from meningococcal meningitis with its expected PDUFA date as April 25, 2020

Click here to read full press release/ article | Ref: Sanofi | Image: Chattanooga Times Free Press