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FDA Breakthrough Therapy Designation: Novartis Gets #36

April 7, 2014

On April 7th, Novartis announces that the FDA Breakthrough Therapy Designation (BTD) is granted for the company’s Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]). In Europe, Australia, and Canada, Bexsero is already approved for Meningococcal disease caused by serogroup B (Meningitis B). Novartis plans on filing in the US as early as the second quarter of this year. In the UK, the Joint Committee on Vaccination and Immunization (JCVI) just recommended in March 2014 including Bexsero in the country’s National Immunization Program (NIP) for “routine use in infants from 2 months of age.”

There are five meningococcal serogroups: A,B,C, W-135, and Y. Serogroup B is the only one for which no broadly-protective vaccine is currently approved in the US. It is estimated that there are 20,000 – 80,000 cases per year worldwide, resulting in long-term disabilities and death.

Dr. Karen Midthun, Director of FDA’s CBER (Center for Biologics Evaluation and Research), wrote in the FDA’s Blog, FDAVoice, on April 7th, about the steps the FDA is taking to work closely with manufacturers of Meningitis B Vaccines. BTD is mentioned as one of the FDA’s regulatory tools that help to bring new treatment options to patients with serious conditions such as Meningitis B. The Blog Post continues:

“ … Although the law generally prohibits FDA from disclosing the existence of pending applications, Novartis has given the agency permission to disclose that the firm plans to submit a BLA for Bexsero … for review in the second quarter 2014. Pfizer, which also is developing a serogroup meningococcal B vaccine, issued a statement on March 20, 2014, in which it acknowledged receiving breakthrough designation from the FDA for its vaccine, and that it intends to submit an application for review by mid-2014 …”.

This is the 36th BTD that is announced by a sponsor company and the 5th BTD for 2014. It is the 4th BTD for Novartis:

Row # Product Name Sponsor Company Indication
1 LDK378 Novartis ALK+


Cell Lung

Cancer (NSCLC)

2 Serelaxin Novartis Acute Heart



3 Bimagrumab Novartis Sporadic


Body Myositis

4 Bexsero Vaccine Novartis Meningococcal B



2 FDA BTDs For Vaccines For Meningococcal B Disease

Row # Product Name Sponsor Company Indication
1 Bivalent rLP2086 Vaccine Pfizer Meningococcal B


2 Bexsero Vaccine Novartis Meningococcal B




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “IMG Carlingford Lough 0617” by Sarah777 at en.wikipedia [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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