FDA to review Sanofi’s MenQuadfi, for meningococcal meningitis

Sanofi’s MenQuadfi Meningococcal Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis will be reviewed for BLA by the FDA, expecting to reach the decision on April 25, 2020.

Sanofi noted in the announcement that the recently submitted BLA includes positive data from Phase II and Phase III clinical trials held in the U.S. to seek an indication for use of the vaccine in persons 2 years of age and older. The drugmaker said that, if approved, MenQuadfi will be available in a fully liquid presentation.

According to the press release by Sanofi, Phase II and Phase III trials have been performed in the U.S., the European Union (EU), Asia and Latin America. Sanofi is conducting additional Phase III trials in these same regions and Africa. The ongoing clinical development program includes different ages ranging from infants 6 weeks of age through older adults, Sanofi explained. Furthermore, given the different vaccines schedules in the U.S. and worldwide, the program’s objective is to assess the vaccine’s ability to help protect individuals from meningococcal meningitis, and address the worldwide needs for meningococcal disease prevention across a broad age range. Sanofi also noted that MenQuadfi’s safety and efficacy data have not yet been evaluated by any regulatory authority.