JUN 01, 2016
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) this week recommended that Abbvie's adalimumab (Humira) be approved for treatment of non-infectious intermediate, posterior and panuveitis in adults.
"Today's CHMP opinion marks a key milestone towards Humira becoming the first approved biologic medication for uveitis, an inflammatory condition of the eye that can impact vision," said Michael Severino, MD, AbbVie executive vice president and chief scientific officer.
Adalimumab targets and blocks TNFα, a specific source of inflammation.
The opinion was based on 2 double-masked, randomized, placebo-controlled clinical trials evaluating the drug in adults with active and noninfectious intermediate, posterior and panuveitis. All subjects were either refractory to corticosteroids or were inappropriate candidates for corticosteroid treatment. In both trials, treated patients achieved a significantly lower risk of uveitic flare or lower risk of reduced visual acuity compared with placebo. The company says the safety profile was consistent with the known safety profile of adalimumab.
Final approval process is currently underway. Since first gaining marketing authorization 13 years ago, Humira has been approved in more than 90 countries. It is currently being used to treat more than 989,000 patients worldwide across 13 globally approved indications.