FDA Grants Orphan Designation To AbbVie’s Humira, Other Drugs

AbbVie Inc. May 15 said that the Food and Drug Administration has granted orphan drug designation to Humira (adalimumab) for treating moderate to severe hidradenitis suppurativa (HS).

The orphan designation, intended for rare conditions and diseases, gives special incentives to sponsors, including tax credits, research and development funding, reduced user fees and seven years of marketing exclusivity upon approval.

HS is a painful, chronic inflammatory skin disease, said AbbVie, which is based in North Chicago, Ill. The FDA is reviewing AbbVie’s supplemental biologics license application for this indication.

Humira is already approved to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ...