AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for Humira (adalimumab) as an investigational treatment for moderate-to-severe hidradenitis suppurativa (HS; Hurley Stage II and III disease).
HS (also referred to as acne inversa) is a chronic inflammatory skin disease with no current cure or approved treatments. It is characterized by inflamed areas typically around the armpits and groin, between the buttocks, and under the breasts.
Humira is a tumor necrosis factor (TNF) blocker already approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis (RA), moderate to severe polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, moderate to severe Crohn’s disease; to induce remission in moderate to severe ulcerative colitis, and to treat moderate to severe chronic plaque psoriasis.
The Company’s Biologic License Application for Humira for the treatment of HS is currently in review by the FDA.
For more information call (800) 633-9110 or visit Humira.com.