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AbbVie’s Humira: Multiple FDA Orphan Drug Designations

May 19, 2015

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


Please Note: “Abstract pills” by Robson# (Flickr: Pills here) [CC-BY-2.0] | Wikimedia Commons.

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