Abbvie Receives Orphan Drug Designation for HUMIRA® from FDA for the Investigational Treatment of Moderate-to-severe Hidradenitis Suppurativa

Industry News

The U.S. Food and Drug Administration has granted Humira (adalimumab) Orphan Drug Designation for the treatment of moderate-to-severe hidradenitis suppurativa (HS) (Hurley Stage II and Hurley Stage III disease).  Humira is a TNF blocker developed and marketed by AbbVie, a biopharmaceutical company headquartered in North Chicago, Illinois.  Currently, Humira is indicated to reduce the signs and symptoms of various forms of arthritis, Crohns’s disease and other inflammatory conditions.  HS, also known as “acne inversa”, is a painful and chronic inflammatory skin disease with no cure and no approved medication.  AbbVie has conducted several clinical trials using Humira to treat HS patients and is seeking FDA approval for HS indication.

 

References:

  1. http://abbvie.mediaroom.com/2015-05-15-AbbVie-Receives-Orphan-Drug-Designation-for-HUMIRA-adalimumab-from-the-U-S-Food-and-Drug-Administration-for-the-Investigational-Treatment-of-Moderate-to-Severe-Hidradenitis-Suppurativa-HS
  2. https://www.humira.com/
  3. https://clinicaltrials.gov/ct2/results/displayOpt?flds=a&flds=b&flds=f&flds=c&submit_fld_opt=on&cond=hidradenitis+suppurativa&intr=Humira&show_flds=Y

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