AbbVie Gets Orphan Drug Status for New Use for HumiraBy
AbbVie reports that the US Food and Drug Administration (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.
Orphan drugs are entitled to seven years of market exclusivity if approved by the FDA for a rare disease. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
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 â€“ namely, painful abscesses and nodules, sinus tracts and scarring.
Humira is AbbVie’s top-selling drug with sales of $12.5 billion, or 63%,of the company’s 2014 sales of $19.960 billion. Humira is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. A key issue for AbbVie in the near-term is the patent expiry for Humira. The United States composition of matter (i.e., the compound) patent covering adalimumab is expected to expire in December 2016, and the equivalent European Union (EU) patent is expected to expire in the majority of EU countries in April 2018.