Abbott Japan and Eisai have submitted an application for marketing authorisation for an additional application of Humira as a treatment for ankylosing spondylitis in Japan.
Ankylosing spondylitis is a chronic inflammatory disease characterised by joint pain and stiffness followed by the development of fusion and rigidity in affected joints, for which there is no specific cure.
The approval request is for Humira, a fully human monoclonal anti-TNF antibody jointly developed by the two companies in Japan, in a pre-filled syringe 40mg/0.8 mL for subcutaneous injection.
If approved, ankylosing spondylitis will be the fourth indication for Humira, following rheumatoid arthritis, psoriasis vulgaris and psoriatic arthritis, and Crohn's disease.
The request is based on clinical studies in patients with active ankylosing spondylitis in Japan, where Humira demonstrated excellent efficacy in improving the signs and symptoms of ankylosing spondylitis and showed tolerability equivalent to that observed in foreign studies.