Roche’s RoActemra receives EU approval for PJIA

Roche has announced that its humanised interleukin-6 receptor antagonist RoActemra has been approved in Europe for treating a rare form of paediatric arthritis.

The European Medicines Agency (EMA) has endorsed the drug as a therapy for polyarticular juvenile idiopathic arthritis (PJIA) among patients aged two years and older who have not responded adequately to treatment with methotrexate.

Data from the phase III trial Cherish showed that RoActemra can deliver clinically meaningful improvement in signs and symptoms of PJIA and has a positive safety profile.

PJIA is characterised by inflammation in five or more joints within the first six months of the disease and often affects smaller joints such as those in the hands and feet.

Dr Hal Barron, Roche's chief medical officer and head of global product development, said: "We can now quickly provide these young patients with this medicine that we hope will help them to better manage their disease symptoms and allow them to pursue an active lifestyle."

Last month, the EMA's Committee for Medicinal Products for Human Use recommended Roche's Erivedge for approval as a therapy option for advanced basal cell carcinoma.