Janssen’s Simponi recommended by CHMP for juvenile arthritis approval

Janssen has announced that its drug Simponi has been recommended for European regulatory approval as a treatment for certain juvenile arthritis patients.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the use of subcutaneous Simponi in combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis.

Intended for children with a body weight of at least 40 kg who have responded inadequately to previous therapy with methotrexate, the treatment has demonstrated efficacy in the phase III GO KIDS study, which involved 173 children.

Polyarticular juvenile idiopathic arthritis is the most common type of arthritis in children under the age of 17, with key symptoms including persistent joint pain, swelling and stiffness.

Dr Newman Yeilding, vice-president and head of immunology development for Janssen Research and Development, said: "We believe the totality of data from the GO KIDS study supports the efficacy and safety of Simponi in the treatment of polyarticular juvenile idiopathic arthritis and look forward to the European Commission's decision."

Simponi is approved in more than 85 countries for a range of rheumatologic indications, including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.