Abbvie receives Orphan Drug Designation for Humira for the investigational treatment of hidradenitis suppurativa

The US Food and Drug Administration (FDA) has granted Abbvie’s Humira® (adalimumab) Orphan Drug Designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (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 hidradenitis suppurativa is currently under review with the agency. Humira is not currently approved by regulatory authorities for the treatment of hidradenitis suppurativa.

Patients living with hidradenitis suppurativa have limited treatment options

“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 recognises the treatment potential of Humira.”

Hidradenitis suppurativa, 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 characterised 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 hidradenitis suppurativa – namely, painful abscesses and nodules, sinus tracts and scarring. The symptoms associated with hidradenitis suppurativa may lead to limited movement and psychological strain that impact the lives of patients.

Physicians typically assess the signs and symptoms of hidradenitis suppurativa 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.

For more information about Abbvie or Humira, please visit

Related topics

Related organisations

Related drugs

Related diseases & conditions