AbbVie Gets Orphan Drug Designation for HumiraBy
AbbVie has been granted orphan drug designation by FDA for Humira (adalimumab) for treating non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis, a group of rare but serious inflammatory diseases of the eye. Humira is AbbVie’s top-selling drug with 2013 global revenues of $10.66 billion and is approved for treating rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.
Humira is currently not approved to treat any form of uveitis, and the drug is in Phase III trials to evaluate its safety and efficacy for treating non-infectious uveitis.
The Orphan Drug Designation program provides orphan status to drugs and biologics tha are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/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.
See related story, “Finding the Niche in Orphan Drugs”