The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trumenba (meningococcal group B vaccine; Pfizer) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B in children ages 1 to 9 years. The Breakthrough designation was based on data from Phase 2 studies which assessed the safety and efficacy of the vaccine in this patient population.
“We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunization with Trumenba,” said Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Vaccines Medical Development, Scientific and Clinical Affairs, at Pfizer.
Trumenba is currently approved for patients 10 to 25 years of age. It can be administered as a 2- or 3-dose schedule depending on the a patient’s risk of exposure and susceptibility to meningococcal serogroup B disease; a study to confirm the 2-dose regimen is ongoing.
For more information visit Pfizer.com.