Janssen receives new juvenile arthritis approval for Simponi in Europe

Janssen has announced that its drug Simponi has been approved in a new juvenile arthritis indication by the European Commission.

The drug has been ratified for use in combination with methotrexate for polyarticular juvenile idiopathic arthritis patients with a body weight of at least 40 kg who have responded inadequately to previous treatment with methotrexate.

Positive data from the GO KIDS clinical trial, conducted in collaboration with Merck Sharp and Dohme, demonstrated the positive response rates associated with the drug, with these findings used to support the European application.

Polyarticular juvenile idiopathic arthritis is the most common type of arthritis in children under the age of 17. It is estimated that nearly 60,000 children in Europe are affected by juvenile idiopathic arthritis.

Dr Newman Yeilding, vice-president and head of immunology development at Janssen Research and Development, said: "We are pleased to make Simponi available for this debilitating form of inflammatory arthritis for patients and caregivers in Europe."

Simponi has been available in Europe since 2009 and is approved in more than 85 countries for rheumatologic indications including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.