AbbVie’s Humira for Chronic Skin Disease Gains Orphan Drug Status
The FDA has dubbed AbbVie’s autoimmune disease treatment Humira an orphan drug for the investigational treatment of moderate-to-severe hidradenitis suppurativa — paving the way for the drug’s ninth indication and seven years added exclusivity.
The designation comes as AbbVie’s patent on Humira is due to expire in December 2016 in the U.S. and in April 2018 in Europe. The therapy already faces competition in India where Zydus Cadila launched a biosimilar under the trade name Exemptia in December.
Hidradenitis suppurativa is an inflammatory skin disease characterized by painful abscesses and nodules and scarring typically located around the armpits, groin and under the breasts. Current treatments include oral or topical antibiotics and oral or injectable corticosteroids, the last of which comes with serious long-term side effects such as osteoporosis.
Humira (adalimumab) blocks tumor necrosis factor, which plays a part in the inflammatory process. The drug already is approved for eight autoimmune indications, including moderate-to-severe rheumatoid arthritis, plaque psoriasis, Crohn’s disease and psoriatic arthritis. — Lena Freund