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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals / Research and Development

FDA: Pfizer’s Meningococcal B Vaccine Is a Breakthrough Therapy

March 24, 2014
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The FDA has granted a breakthrough therapy designation to Pfizer’s investigational bivalent rLP2086 meningococcal B vaccine, the drug giant said Thursday.

The agency backed its decision using data from two Phase II safety and immunogenicity trials.

Breakthrough therapy designation is intended to expedite development and review of therapies for serious and life-threatening illnesses. The designation provides drug sponsors with increased agency interaction throughout the development process as well as eligibility for accelerated approval and priority review.

Pfizer has already engaged in discussions with the FDA, the company says, and plans to submit a BLA for rLP2086 by the middle of this year. — Lena Freund

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