EMEA granted Novartis’ Ilaris® accelerated approval as a treatment for cryopyrin-associated periodic syndrome (CAPS) in adults and children aged four years and over. The fully human mAb is the first treatment to be approved in the EU for CAPS patients as young as four years of age, including patients with neonatal-onset multisystem inflammatory disease (NOMID), the most debilitating form, according to the company adds.
EU approval follows clearance earlier this year by regulatory authorities in the U.S. (June) and Switzerland (July). In the U.S. Ilaris is sanctioned for treating the familial cold autoinflammatory syndrome and Muckle-Wells syndrome forms of CAPS. Swiss approval covers all three forms of the disease, including NOMID. Priority reviews are ongoing in other countries including Australia, Brazil, and Canada.
Ilaris targets interleukin-1 beta, which is overexpressed in CAPS patients. The drug is administered by injection once every two months. Clinical trials are also ongoing in other diseases involving Interleukin-1 beta, including COPD, type 2 diabetes, systemic juvenile idiopathic arthritis (SIJA), and gout.
Ilaris has orphan drug designation in the EU, U.S., and Switzerland for the treatment of SJIA. Fast track status for the SJIA indication has also been granted in the U.S.
“Initially we studied Ilaris in a very rare disease with a well-understood genetic profile,” comments Joe Jimenez, CEO at Novartis’ pharmaceutical division. “Now that its efficacy has been proven, we are able to move ahead rapidly with development in other diseases characterized by the same inflammatory process.”