FDA Grants Orphan Drug Status to Humira for HS

The FDA has granted orphan drug designation to Humira for the treatment of moderate to severe hidradenitis suppurativa (HS; Hurley stage II and III).

Symptoms of HS, which is sometimes referred to as acne inversa, include painful abscesses and nodules, sinus tracts, and scarring; the inflamed areas are often located around the armpits and groin, between the buttocks, and under the breasts.

The FDA grants orphan drug status for novel drugs or biologics to treat rare medical diseases or conditions that affect less than 200,000 people in the United States and/or affect more people but not enough to recoup the costs of developing and marketing the drug. This designation means Humira would have a 7 years of market exclusivity after approval, tax credits for clinical research costs, and application fee reductions.

Reference:

Abbvie receives orphan drug designation for Humira (adalimumab) from US Food and Drug Administration for the investigational treatment of moderate-to-severe hidradenitis suppurativa [press release]. Abbvie. May 15, 2015. http://abbvie.mediaroom.com/2015-05-15-AbbVie-Receives-Orphan-Drug-Designation-for-HUMIRA-adalimumab-from-the-U-S-Food-and-Drug-Administration-for-the-Investigational-Treatment-of-Moderate-to-Severe-Hidradenitis-Suppurativa-HS. Accessed May 2015.