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