AbbVie’s Humira: Multiple FDA Orphan Drug Designations
Orphan drug companies have used with tremendous success as part of their drug life cycle management, the strategy to extend the life of their product by devising a succession of multiple discrete indications for the orphan drug. This strategy is critical to the continued financial success for orphan drug companies, especially when facing the challenges of generic competition and the demise of the traditional blockbuster drug strategy. The advantage of using multiple indications is that it allows a company to progressively expand the drug’s market.
AbbVie announces on May 15th that Humira (Adalimumab) receives FDA Orphan Drug Designation (ODD) for the investigational treatment of moderate to severe Hidradenitis Suppurativa (HS). AbbVie’s supplemental Biologic License Application (sBLA) for FDA approval for Humira for this indication, is currently under review.
HS, also known as acne inversa, is a chronic skin disease with painful and recurrent boil-like lumps (nodules) under the skin. Nodules can break open causing abscesses. There is currently no cure or approved drugs.
AbbVie’s Humira receives FDA ODD for the following indications:
|Num||FDA ODD Date/Approval Date||Indication|
|1||03-21-2005/ 02.21.2008 & 09.30.2014||Moderately to severely active polyarticular juvenile idiopathic arthritis for 2 yrs & older|
|2||10.19.2006/ 09.23.2014||Pediatric Crohn’s Disease|
|3||05.11.2011||Pediatric Ulcerative Colitis|
|4||05.13.2014||Non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis|
|5||05.13.2015||Moderate to severe hidradenitis suppurativa|
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