The anti-inflammatory drug Humira (adamumumab) of ibuprofen was approved by Japan for the treatment of noninfectious uveitis

Humira, the flagship product of American biotechnology giant abbvie, received good news in the US and EU regulation at the same time in July this year In the United States, the FDA approved Humira for the treatment of adult patients with noninfectious middle, post and total uveitis; previously, the FDA granted Humira the orphan drug status for the treatment of the indication in 2014 This approval makes Humira the first and only non glucocorticoid therapy approved by FDA to treat adult patients with noninfective middle, post and total uveitis It also marks the 10th indication approved by Humira in the United States In the European Union, Humira has been approved by the European Commission (EC) for the treatment of adult patients with noninfectious middle, post and total uveitis who have insufficient response to glucocorticoid treatment, or need to reduce the use of glucocorticoid, or are not suitable for glucocorticoid treatment; the clinical data show that Humira can reduce glucocorticoid in patients with remission of glucocorticoid treatment Use Recently, Humira was approved by Japanese regulatory authorities for the treatment of noninfectious middle, post and total uveitis So far, Humira has become the first biological treatment option approved by the United States, Europe and Japan for the treatment of non infectious middle, post and total uveitis with or without potential diseases Noninfectious uveitis is a group of eye diseases characterized by uveitis, which can seriously damage the vision, leading to vision loss or blindness Worldwide, noninfective uveitis is the third leading cause of preventable blindness The diagnosis and treatment of noninfectious uveitis is very complex, and there is no generally accepted treatment guidelines At present, glucocorticoid is the main treatment choice after excluding potential factors (such as infection) However, this regimen is not suitable for all patients and may be accompanied by serious long-term ocular side effects, including glaucoma and cataracts Glucocorticoid therapy is not appropriate for patients with underlying diseases Humira will provide an important treatment option for this group Humira has been approved for the treatment of noninfectious uveitis in the middle, posterior and whole stages, based on data from two key phase III clinical studies, visual-i and visual-ii The results showed that patients with active and controlled noninfectious uveitis had significantly lower risk of flare or decreased visual acuity after treatment with Humira compared with placebo In the study, patients with uveitis were treated with Humira every other week for safety consistent with the known safety of Humira Humira is the first approved anti-tumor necrosis factor TNF - α drug in the world, which is also the best-selling anti-inflammatory drug in the world Since its launch 13 years ago, the drug has been approved by more than 90 countries in the world, 14 indications have been approved worldwide, and 10 indications have been approved in the U.S market At present, more than 980000 patients in the world are receiving Humira treatment Humira is a super heavyweight product of Aberdeen It has been the world's "medicine king" for several years in a row In 2015, the sales volume of the drug reached 14 billion US dollars, and the clinical indications are also increasing steadily At present, the wave of bio generic drugs has come, but the industry believes that the impact on Humira is very limited Some analysts predict that Humira's sales will still reach 14.8 billion US dollars in 2020 Alberto said it plans to hit the $18 billion mark in 2020 Original source: abbvie and Eisai objective addition nal approval for new indication of full human anti TNF - α Mo noclinal anti Humira? in the Treatment of non-infectious Uveitis