FDA Grants AbbVie Rare Eye Disease Drug Orphan Drug Designation

The FDA has announced that AbbVie’s Humira (adalimumab) drug has been granted orphan drug designation. The orphan drug designation is intended for the development of drugs to treat rare diseases that affect fewer than 200,000 people in the U.S. Humira treats non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis, all of which are rare and dangerous inflammatory eye diseases.

Humira is currently under investigation by AbbVie for its safety and efficacy in Phase III trials. Currently, the drug is not approved for treating uveitis. Uveitis refers to several different eye diseases, which can cause damage to eye tissues and vision loss. The cause of uveitis isn’t yet known, but it can be caused by autoimmune diseases, medicines, surgery, trauma, or infection. Blurred vision, eye pain, redness, light sensitivity, and vision loss all are symptoms of uveitis, which is considered to cause 10 to 15 percent of all blindness cases in the US.

Scott Brun, vice president of Pharmaceutical Development at AbbVie commented on the drug’s new orphan drug designation. “Few well characterized treatment options are available for patients suffering from uveitis, and the orphan drug designation recognizes the significant unmet need that exists within this disease,” he said. “AbbVie remains committed to the ongoing development of Humira to treat a variety of autoimmune diseases where patients have the potential to benefit.”

Humira is still being studied, and there have been documented risks to continued Humira risk. As Humira suppresses the body’s immune system, patients can become more susceptible to developing TB, fungal infections, hepatitis B, fever, cough, or sores. Patients also increase their risk for obtaining lymphoma or other cancers, such as basal cell and squamous cell skin cancer. Researchers are still assessing the depth of these risks in company studies.