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FDA Breakthrough Therapy Designation: Pfizer Gets #35

March 20, 2014

On March 20th , Pfizer announces that the FDA Breakthrough Therapy Designation (BTD) is granted for the company’s investigational vaccine candidate, bivalent rLP2086, for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10-25 years of age.

This is the 35th BTD that is announced by a sponsor company and the fourth BTD for 2014. It is the second BTD Pfizer receives:

Row Num

Drug Name

Indication

1

Palbociclib Breast Cancer

2

Bivalent rLP2086   Vaccine Meningococcal BDisease

.

The BTD is based in part on data from two clinical trials that are studying the safety and immunogenicity of rLP2086. In late 2012, a Phase III program started with the initiation of a large scale safety study. Pfizer plans on submitting a Biologics License Application (BLA) to the FDA by mid-2014.

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.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

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

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

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3 Comments
  1. Roland Bracken permalink

    Is the the CBER or CDER

    ________________________________

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