June 18, 2009 / 5:28 AM / 10 years ago

UPDATE 1-US approves Novartis auto-inflammatory drug

* First approved treatment for patients as young as four

* Long-term consequences can be serious, even fatal

(Adds details)

ZURICH, June 18 (Reuters) - U.S. regulators have approved Novartis AG’s NOVN.VX Ilaris to treat children and adults with a rare but potentially fatal auto-inflammatory disease, the Swiss drugmaker said on Thursday.

It is the first approved treatment for patients as young as four who suffer from two forms of cryopyrin-associated periodic syndrome (CAPS), whose symptoms can include debilitating fatigue, rash, fever, headaches, joint pain and conjunctivitis, Novartis said in a statement.

CAPS is caused by a single gene mutation that leads to overproduction of interleukin-1 beta, which causes sustained inflammation and tissue damage.

Long term consequences may be serious and potentially fatal, including deafness, bone and joint deformities, central nervous system damage leading to visual loss, and possible kidney failure and early death.

Ilaris is the first approved treatment for patients as young as four years old suffering from two forms of CAPS, familial cold auto-inflammatory syndrome and Muckle-Wells syndrome, Novartis said. (Reporting by Sam Cage; Editing by Jon Loades-Carter)

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