Lilly bags expanded EU approval for Taltz

The European Medicines Agency has expanded the reach of Lilly's Taltz (ixekizumab) to include the treatment of adults with active ankylosing spondylitis and active non-radiographic axial spondyloarthritis (nr-axSpA).

In both cases, the approval covers patients who have not had responses to conventional therapies.

AxSpA is a chronic, immune-mediated inflammatory condition characterised by inflammation of the sacroiliac joints (sacroiliitis), inflammation of the spine or both resulting in chronic back pain, fatigue and significantly reduced function and quality of life. Around one in 200 people are thought to have the condition.

“Many patients living with axSpA suffer from chronic inflammatory back pain and the associated loss of sleep and mobility for many years before being diagnosed, and we’re pleased to be able to offer a new treatment option,” said Dr Arash Tahbaz, senior medical director Eli Lilly and Co, UK and Northern Europe.

“As a Rheumatologist, I welcome the license of ixekizumab for treatment of axial spondyloarthritis patients in the UK. The clinically meaningful benefits seen in the phase three trials supports ixekizumab to be an effective new option in the treatment paradigm for these patients,” added Dr Raj Sengupta Consultant Rheumatologist, Royal National Hospital for Rheumatic Diseases.

AxSpA comprises a spectrum of disease diagnostically divided into two subsets termed r-axSpA (synonymous with the older term ankylosing spondylitis (AS)) and nr-axSpA. R-axSpA and nr-axSpA results in a similar burden of disease on health-related quality of life.

The marketing authorisation for Taltz in axSpA was based on findings from three randomised placebo-controlled trials designed to assess the efficacy and safety in both r-axSpA and nr-axSpA, which all showed a significant reduction of the signs and symptoms of disease, the firm noted.

Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. It was approved for psoriatic arthritis in 2018 and plaque psoriasis in 2016.