European Commission Approves Canakinumab in SJIA

Megan Brooks

Disclosures

September 03, 2013

The European Commission has approved canakinumab (Ilaris, Novartis) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.

Canakinumab can be used alone or in combination with methotrexate.

The approval follows a positive endorsement of canakinumab for SJIA by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July, as reported by Medscape Medical News.

SJIA is a rare and disabling form of childhood arthritis characterized by prolonged high, spiking fevers; rashes; and arthritis in the small joints of the hands, wrists, knees, and ankles.

Canakinumab is the first interleukin-1β (IL-1β) inhibitor for the treatment of SJIA and is the only treatment approved specifically for SJIA that is given as a monthly subcutaneous injection, Novartis said in a statement announcing the approval.

The approval was based on 2 phase 3 studies involving patients aged 2 to 19 years with SJIA. In one study, 84% of patients treated with a single subcutaneous dose of canakinumab met the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30) at day 15, compared with 10% of placebo recipients, the company said.

In the open-label part of the other study, 62% of patients were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of this study, there was a 64% relative reduction in the risk for flare among patients in the canakinumab group compared with those in the placebo group (hazard ratio, 0.36; 95% confidence interval, 0.17 - 0.75).

Data from a pooled efficacy analysis showed that after 12 weeks of canakinumab treatment, 61% of patients reached an adapted pediatric ACR70 and 28% of patients had inactive disease.

"The EU approval of Ilaris provides patients suffering from SJIA with a convenient new treatment option offering a favorable benefit-risk profile, administered as a single monthly subcutaneous injection," Timothy Wright, MD, global head of development for Novartis Pharmaceuticals, said in a statement. "This represents another significant milestone in the development of Ilaris as a novel therapy for patients with rare, inflammatory diseases, where interleukin-1 beta plays a key role."

Canakinumab is approved for the treatment of SJIA in the United States and for the symptomatic treatment of refractory acute gouty arthritis in the European Union. The drug is also approved in more than 60 countries, including in the European Union, United States, Switzerland, and Japan, for the treatment of cryopyrin-associated periodic syndromes, a rare, genetic disorder with debilitating symptoms.

Novartis said canakinumab is also being investigated in several inflammatory diseases in which IL-1β is a key component of disease pathogenesis, including tumor necrosis factor receptor–associated periodic syndrome, colchicine-resistant familial Mediterranean fever, and hyper-IgD syndrome.

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