The US Food and Drug Administration (FDA) has granted orphan drug designation for AbbVie’s HUMIRA (adalimumab) to treat non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
The company is currently evaluating the efficacy and safety of HUMIRA for treatment of non-infectious uveitis in a Phase III clinical development programme.
So far, HUMIRA is not approved to treat any form of uveitis, a general term that encompasses several inflammatory eye diseases.
The exact cause of uveitis is unknown and the condition could be caused by an infection, autoimmune disease, medication, surgery or eye trauma.
Symptoms of this condition may include vision loss, blurred vision, eye pain and redness, as well as sensitivity to light.
AbbVie vice-president of pharmaceutical development Scott Brun said few well characterised treatment options are available for patients suffering from uveitis.
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By GlobalData“AbbVie remains committed to the ongoing development of HUMIRA to treat a variety of autoimmune diseases where patients have the potential to benefit,” Brun said.
HUMIRA is a prescription medicine used to reduce the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adults; moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children four years of age and older; psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in adults.
It is also indicated to reduce moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments.
The TNF blocker medicine affects the immune system and can reduce the ability to fight infections.
Serious infections happened in people taking HUMIRA include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body.