Abbvie Korea, the Korean offshoot of the global biopharmaceutical company, said Tuesday it received the EU’s green light to use Humira (ingredient: adalimumab) to treat chronic non-infectious anterior uveitis (CHMP) in children.
“This approval is a significant milestone for pediatric uveitis patients and their caregivers who have had no biological treatment until now,” said an Abbvie Korea한국애브비 official.
Humira is the first and only biologic therapy approved in Europe to treat the disease in CHMP pediatric patients from two years of age who have had an inadequate response to standard therapy or when standard treatment was inappropriate, the company said.
Uveitis is an inflammation of the iris, choroid and the ciliary body in the eye. If left untreated, the disease can cause severe vision loss, the company said
“The SYCAMORE study showed treatment with Humira plus methotrexate combination significantly reduced the duration of treatment failure compared to the placebo plus methotrexate combo. Results showed Humira might protect children against eyesight complications that arise from [the disease],” said Severance Hospital Professor Lee Seung-chul.
Humira is an immune system drug that treatment indicated for nine conditions including plaque psoriasis, rheumatoid arthritis, Chron’s disease, and ulcerative colitis in the EU. It currently has the approval to treat 14 conditions in Korea as of Dec. 2016.
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