Ilaris gets EU approval in Europe for gouty arthritis patients

March 4, 2013 | By Márcio Barra

Ilaris, from Novartis, is one of those cases where a company, in this case, Novartis, knows what it’s doing with its orphan drug portfolio. Just take a drug that was designed and is already approved for a rare disease, and try to see if it can work in other diseases. A good example of this is Gleevec (or Glivec for Europe), first approved for chronic myelogenous leukemia, then for Ph+ ALL  myeloplastic /myeloproliferative diseases. And that’s what Novartis did again with Ilaris.


Ilaris (canakinumab) was approved back in 2009 by the FDA and EMA for the treatment of cryopyrin-associated periodic syndromes, or CAPS, a suite of rare, life-long, genetic autoinflammatory diseases including familial cold autoinflammatory syndrome, Muckle–Wells syndrome and others. Ilaris is a biologic drug, a selective, fully human, monoclonal antibody that inhibits IL-1 beta, a part of the body’s immune system defenses that, when over expressed, leads to inflammation.

Now, Ilaris was received approval from the CHMP and the European Comission for the  treatment of patients with frequent (at least three per year) attacks of acute gouty arthritis, where the body has a strong inflammatory response to the formation of uric acid crystals in affected joints (tipycally the toes, foot, ankle and knees). It’s a very painful syndrome, and many patients find out that they can’t be treated with typical painkillers (NSAIDS), colchicine or repeated courses of corticosteroids. Ilaris can be the much expected relief for these patients, judging from the positive data collected from the Phase III clinical trial undertaken to support this new indication.

The FDA however, while recognizing the efficacy in patients non-responsive to typical treatments, demanded more safety information from Novartis back in 2011 over concerns of serious infection risks.  This might be familiar to some.

Ilaris is currently sold for nearly $100,000 annually in the US for the treatment of CAPS. The price of Ilaris in Europe for the new indication is still unknown.



The Wall Street Journal 

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