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What Is The Status Of Sanofi’s Orphan Drug Signifor (Pasireotide) For Cushing’s Disease ?

December 15, 2012

On December 14, 2012, the FDA approves Signifor (Pasireotide) injection for the treatment of Cushing’s Disease. Per the FDA News Release, the following 3 post marketing studies for Signifor is being required :

  1. A clinical trial to assess high blood sugar (Hyperglycemia) management
  2. Long-term prospective observational cohort study (registry) Cushing’s Disease patients treated with Signifor
  3. Focused safety monitoring for reports of Hyperglycemia, acute liver injury, and adrenal insufficiency.

Signifor is the 1st drug to treat Cushing’s Disease in the US.  The drug is already approved for Cushing’s Disease in Europe and other regulatory filings are underway worldwide.

On November 7, 2012, the FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) unanimously votes 10-0 in favor of the injectable orphan drug Signifor (Pasireotide) for the treatment of Cushing’s Disease.

References

FDA Orphan Drug Product Database Record for Pasireotide

Novartis November 7, 2012 News Release

Novartis December 14, 2012 News Release

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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