May 27, 2016
AbbVie, a global biopharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for HUMIRA® (adalimumab) for the treatment of non-infectious uveitis in adult patients who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is not appropriate. HUMIRA can also decrease the use of corticosteroid in patients dependent with corticosteroid. HUMIRA would become the first and only biologic treatment available for non-infectious intermediate, posterior and panuveitis if granted marketing authorization by the European Commission.
“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. Current treatment options are limited and sometimes ineffective. Building on more than 18 years of clinical experience with HUMIRA across indications, we hope to make an impact on the lives of more patients with unmet needs,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.
According to Glenn J. Jaffe, M.D., professor of ophthalmology, Robert Machemer M.D. professor of ophthalmology and chief, Division of Retinal Ophthalmology, at Duke University, Durham: “With limited treatment options for non-infectious uveitis, this recommendation is a step toward progress for people living with a disease that has potentially profound effects on vision. The data from the VISUAL clinical trial program demonstrate the safety and efficacy profile of HUMIRA in patients living with particular forms of non-infectious uveitis.”