Ilaris regulatory update

EMA’s CHMP recommended expanding the label of Ilaris canakinumab from Novartis to include the treatment of 3 auto-inflammatory periodic fever syndromes in patients ages ≥2. The syndromes include tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF). The committee also recommended amending the existing indication of treatment of cryopyrin-associated periodic syndromes (CAPS) in patients ages ≥2 to remove the body weight restriction. The human anti-IL-1 beta mAb is approved for the indication in patients with a body weight of ≥7.5 kg. Ilaris is also approved in Europe to treat Still’s disease and gouty arthritis...