FDA Breakthrough Therapy Designation: Pfizer’s Meningococcal B Vaccine Available In US
Pfizer announces November 18th that Trumenba (Meningococcal Group B Vaccine) is now available for healthcare providers, retail pharmacies, hospitals and college health centers to order in the US. It is the first and only FDA-approved vaccine for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in people ages 10 – 25.
Just 3 weeks ago on October 29th, the FDA grants Accelerated Approval of Trumenba. Trumenba is reviewed and approved under the FDA’s Breakthrough Therapy Designation (BTD) and Priority Review programs. Pfizer receives the FDA BTD in March 2014. Part of the FDA Accelerated Approval process requires Pfizer to conduct further studies to verify Trumenba’s effectiveness against additional strains of N. meningitidis serogroup B.
Pfizer’s competitor for this indication in the US is Novartis’s Bexsero Vaccine that receives the FDA BTD in April 2014. Bexsero is not yet approved of in the US. In Europe, Australia, and Canada, Bexsero is already approved for Meningococcal disease caused by serogroup B.
Please Note: “Vaccine” by John Keith (Photographer) [Public domain, NIH], via Wikimedia Commons | Wikimedia Commons.
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