Janssen’s Stelara approved for psoriatic arthritis in EU

Janssen has been granted European Commission approval for the use of its drug Stelara for the treatment of active psoriatic arthritis in adult patients.

The product has been ratified for use alone or in combination with methotrexate among patients whose response to previous non-biological disease-modifying antirheumatic drug therapy has been inadequate.

It is the first in a new class of biologics for the treatment of this disease, with data from two pivotal phase III Psummit trials having demonstrated the safety and efficacy of the drug in this indication.

Psoriatic arthritis is a chronic autoimmune disease that affects approximately 4.2 million people across Europe, for which there is currently no cure.

Dr Jerome Boscia, vice-president and head of immunology development at Janssen research and development, said the approval "brings an important new therapeutic option to patients and marks the first treatment approved for this devastating and complex disease since the introduction of anti-tumour necrosis factor-alpha agents".

This comes in the same week that the company also received a Committee for Medicinal Products for Human Use recommendation for EU approval of its new type 2 diabetes therapy Invokana.