AbbVie Receives FDA Orphan Drug Designation for Humira for the Investigational Treatment of Moderate-to-Severe Hidradenitis Suppurativa

May 14, 2015

AbbVie announced that the FDA has granted Humira® (adalimumab) orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS) (Hurley Stage II and Hurley Stage III disease), a painful, chronic inflammatory skin disease. AbbVie's supplemental Biologic License Application seeking FDA approval for the use of Humira in patients with moderate-to-severe HS is currently under review with the agency. Humira is not currently approved by regulatory authorities for the treatment of HS.

"Patients living with hidradenitis suppurativa have limited treatment options and often experience severe, painful symptoms that can significantly impact their lives," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We are committed to researching treatment options to address the unmet needs of the dermatology community and we are pleased that the FDA has issued this designation and recognizes the treatment potential of Humira."

HS, sometimes referred to as "acne inversa" by dermatologists, is a painful, chronic inflammatory skin disease for which there is no known cure and no approved medication. The disease is characterized by inflamed areas typically located around the armpits and groin, between the buttocks and under the breasts. A number of physical signs are associated with HS – namely, painful abscesses and nodules, sinus tracts and scarring. The symptoms associated with HS may lead to limited movement and psychological strain that impact the lives of patients.

Physicians typically assess the signs and symptoms of HS on a scale developed from a clinical measure of severity called the Hurley Staging System. Hurley Stage II manifests with recurrent abscesses with sinus tracts and scarring, single or multiple widely separated lesions. In Hurley Stage III, patients present with either spread or interconnected abscesses.

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