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FDA Breakthrough Therapy Designation: Novartis’ Bexsero Vaccine Gets Accelerated Approval

January 24, 2015

The FDA announces January 23rd, that Novartis’ Bexsero vaccine is approved for the prevention of invasive Meningococcal Disease caused by Neisseria meningitidis serogroup B, in people ages 10 – 25 years of age. The FDA used the Accelerated Approval regulatory pathway to approve Bexsero – 2 months in advance of its Priority Review goal date.As part of the accelerated approval process, the manufacturer will conduct further studies to verify Bexsero’s effectiveness against additional strains of N. meningitidis serogroup B.”

In April 2014, Novartis announces that the FDA Breakthrough Therapy Designation (BTD) is granted to Bexsero.  With the FDA’s approval, Bexsero is now licensed in 37 countries. Bexsero’s 2-dose regimen offers a flexible dosing schedule, with the first and second doses administered at least 1 month apart.

Per Karen Midthun, M.D., Director of the FDA’s Center for Biologics Evaluation and Research (CBER):

“With today’s approval of Bexsero, the U.S. now has two vaccines for the prevention of serogroup B meningococcal disease. The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”

Bexsero is the second vaccine the FDA approves for meningococcal  serogroup B in the last several months – in October 2014, Pfizer’s Meningococcal Group B vaccine, Trumenba, receives FDA Accelerated Approval after receiving the FDA’s BTD.  Trumenba became available in the US in November 2014. Trumenba is administered as a 3-dose series at months 0, 2, and 6 in the 10 – 25 year old age group.

There are five meningococcal serogroups: A,B,C, W-135, and Y. Trumenba and Bexsero are now approved by the FDA to prevent type B. Two existing vaccines, Menactra and Menveo, prevent the other four types of bacterial meningitis and are currently recommended by the CDC for all preteens and adolescents. Many schools and colleges require students to get a meningitis vaccine before starting classes. According to the CDC, in the US in 2012, there were about 500 cases of Meningococcal Disease, with 160 cases or approximately 32%, caused by serogroup B. The CDC said that 10 – 15% of these cases are fatal and that for those who survive, 11 – 19% suffer permanent disabilities.

FDA CBER BTDs Receiving Approval (as of 01/23/15)

The FDA CBER Breakthrough Therapy Designations receiving approval (as of 01/23/15) as announced by the sponsoring companies, in ascending chronological “FDA Approval Date” order, are as follows:

Drug Name FDA Approval Date Sponsor Company Indication
Trumenba (Meningococcal Group B Vaccine) ***** 10.29.14 Pfizer Meningococcal B Disease
Bexsero (Meningococcal Group B Vaccine) ***** 01.23.15 Novartis Meningococcal B Disease

***** Accelerated Approval.


Novartis January 23, 2015 Press Release


FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Flickr – Nicholas T – Bows” by Nicholas A. Tonelli from Pennsylvania, USA (Bows) [CC-BY-2.0] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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