AbbVie and Eisai celebrate approval of new Humira indication
pharmafile | September 28, 2016 | News story | Research and Development, Sales and Marketing | AbbVie, Eisai, Humira
AbbVie and Eisai have announced the Japanese approval of a new indication for the former’s anti-TNF-α monoclonal antibody formulation Humira (adalimumab): the treatment of non-infectious intermediate, posterior and panuveitis regardless of underlying disease.
The news is hot on the heels of the FDA’s approval of the first Humira biosimilar this week.
Non-infectious uveitis is a disease group characterised by inflammation of the uvea, the middle layer of the eye which can lead to reduced vision or vision loss and is the third-leading cause of preventable blindness worldwide. It can be difficult to treat and there is currently no universally accepted guideline for treatment; corticosteroids are predominantly used in patients, but have inconsistent effectiveness and can cause serious ocular side-effects.
Humira targets and helps block TNF-α, a source of inflammation that can be a key part of the illness. Its new approval comes following the positive results of two Phase III trials and an extension study which found that patients suffering from active and controlled iterations of the illness had a significantly lower risk of treatment failure when administered with Humira compared to placebo.
Eisai is responsible for distributing the antibody in Japan on behalf on AbbVie. The two companies are co-promoting Humira for indications in rheumatoid arthritis, plaque psoriasis, anthropathic psoriasis, ankylosing spondylitis and juvenile arthritis. Eisai subsidiary EA Pharma is promoting the drug alongside AbbVie for gastrointestinal conditions such as ulcerative colitis, Crohn’s disease and intestinal Bechet’s disease.
Matt Fellows
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