The European Medicines Agency (EMA) has approved Roche’s autoimmune drug RoActemra for a rare form of arthritis in children.
Specifically, the EU medicines regulator has given RoActemra (tocilizumab) the green light to treat children with polyarticular juvenile idiopathic arthritis (PJIA) – a rare, chronic and debilitating form of childhood arthritis.
The medicine can be used to treat patients two years of age and older who have not responded adequately to treatment with methotrexate (MTX), a disease-modifying anti-rheumatic drug.
RoActemra, also known as Actemra outside of Europe, is already approved for moderate to severe active rheumatoid arthritis in adults, and systemic juvenile idiopathic arthritis in children.
The drug brought in 842m Swiss francs ($900m) last year for these indications and Roche will hope that by extending its licence, this will increase RoAcemtra’s overall revenue, and bring it to blockbuster status.
These hopes will be boosted by an earlier than expected approval in PJIA, with the EMA’s decision coming just one month after a positive Committee for Medicinal Products for Human Use (CHMP) opinion. It usually takes three months for a drug to receive final approval by the Agency after the CHMP has made a recommendation.
Hal Barron, Roche’s chief medical officer, welcomed the EMA’s swiftness, adding: “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.”
Despite being rare, this is not the first drug to receive marketing approval for this disease, with Bristol-Myers Squibb’s Orencia also holding a European licence to treat PJIA.
PJIA is a form of juvenile idiopathic arthritis, also known as juvenile rheumatoid arthritis, and affects around 100 in every 100,000 children, with PJIA accounting for around 30 per cent of cases.
The condition is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body, such as those in the hands and feet.