FDA grants orphan drug status to AbbVie's Humira
- There is a new treatment option for uveitis (a group of inflammatory eye diseases) thanks to FDA granting Humira (adalimumab) orphan drug status.
- Humira is already a $2.6 billion drug, which is used to treat a variety of inflammatory conditions.
- Humira is in phase 3 trials.
Uveitis is an inflammatory eye condition that leads to 10% to 15% of all cases of blindness in the U.S. Though treatment options exist, regulators agree that there is still an unmet medical need. Therefore, Humira, which is currently in phase 3 trials for the treatment of non-infectious uveitis, has been granted orphan drug status.
Humira is currently a $2.6 billion drug, widely used for its anti-inflammatory efficacy in the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and chronic plaque psoriasis.
- Pharma Times Humira wins orphan status for uveitis