Janssen receives CHMP backing for Simponi spondyloarthritis approval

Janssen has been granted a recommendation for EU approval of its drug Simponi in the treatment of severe active non-radiographic axial spondyloarthritis.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval for the use of the subcutaneous drug in adult patients with objective signs of inflammation who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs.

Data from the phase III GO-AHEAD trial, conducted in partnership with Merck Sharp and Dohme, has demonstrated the safety and efficacy benefits of this therapy compared to placebo.

A final approval decision from the European Commission is expected during the third quarter of 2015.

Dr Newman Yeilding, vice-president and head of the immunology development at Janssen Research and Development, said: "We are committed to advancing innovative therapeutics for patients with rheumatic diseases, and we look forward to the European Commission's decision later this year."

The product is also intended for the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.