FDA grants orphan drug status to Humira for treatment of hidradenitis suppurativa

AbbVie announced today that the FDA has granted orphan drug designation to Humira for treating moderate-to-severe hidradenitis suppurativa.

The supplemental biologic license application by Abbvie seeking the agency’s approval for the use of Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS; Hurley Stage II and Hurley Stage III disease) is being reviewed by the FDA, according to a press release.

HS, sometimes referred to as “acne inversa,” is characterized by inflamed areas often located around the armpits and groin, between the buttocks and under the breasts, the release stated. Painful abscesses and nodules, sinus tracts and scarring are symptoms associated with HS. Signs and symptoms of HS are typically assessed by physicians using the Hurley Staging System.

“We are committed to research treatment options to address the unmet needs of the dermatology community and are pleased that the FDA has issued this designation and recognizes the treatment potential of Humira,” Scott Brun, MD, vice president of pharmaceutical development for AbbVie, said in the release.

The FDA grants orphan drug status for novel drugs or biologics to treat rare medical diseases or conditions that affect fewer than 200,000 people in the United States, or that affect more than 200,000 people but are not expected to recover the costs of developing and marketing the drug, according to the release. Incentives included with the designation include 7 years of market exclusivity after the drug’s approval, tax credits for clinical research costs and application fee reductions.

Orphan designation request approval does not alter the standard regulatory requirements and process for obtaining marketing approval for an investigational use, in which the sponsor must establish safety and efficacy of a compound through studies, the release stated.

Adalimumab is a prescription medication with indications including the treatment of moderate-to-severe chronic plaque psoriasis, psoriatic arthritis, moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease and ulcerative colitis for adults, according to the release.

Reference: www.abbvie.com.