AbbVie's HUMIRA® (Adalimumab) Receives Positive CHMP Opinion to Treat Children and Adolescents With Severe Chronic Plaque Psoriasis

– Marketing Authorization Decision Expected from the European Commission in the Second Quarter –

NORTH CHICAGO, Illinois, Feb. 27, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the European 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 severe chronic plaque psoriasis in children and adolescents from four years of age. If granted marketing authorization by the European Commission, HUMIRA may become the first treatment available for severe chronic plaque psoriasis in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

"The positive response from the CHMP marks an important step in addressing the needs of children and adolescents living with severe plaque psoriasis in Europe," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Building on more than 16 years of clinical experience with HUMIRA, we look forward to the opportunity to make a positive impact on the lives of pediatric plaque psoriasis patients."

The positive opinion is based on the results of a Phase 3 study, which will be presented at an upcoming medical meeting. The review of the marketing authorization application (MAA) is being conducted under the centralized licensing procedure. If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 843,000 patients worldwide¹ across 10 globally approved indications.²

About Pediatric Chronic Plaque Psoriasis
According to estimates from the World Health Organization, pediatric psoriasis occurs in 0.70 percent of the pediatric population,³ with no significant difference by gender.⁴ The chronic autoimmune disease is characterized by the rapid and excessive accumulation of skin cells, which form thick patches of inflamed, scaly skin.⁵ Pediatric psoriasis has similar characteristics to adult psoriasis, but in children, the psoriatic lesions are typically smaller, thinner, and less scaly.⁴ Beyond the physical challenges of managing the chronic skin disorder, it is also considered to have significant emotional and psychological effects.⁶