ZURICH - The European Union has approved Novartis AG's Ilaris to treat children and adults with a rare but potentially fatal inflammatory disease, the Swiss drugmaker said on Wednesday. Novartis said in a statement the accelerated EU decision follows approvals in the United States and Switzerland.
It said Ilaris is the only approved treatment in the EU for patients who suffer from two forms of cryopyrin-associated periodic syndrome (CAPS), whose symptoms can include debilitating fatigue, rash, fever, headaches, joint pain and conjunctivitis.
Helvea analyst Karl-Heinz Koch said the global market for CAPS was estimated at about $50 million, but noted Novartis recently presented promising data for Ilaris in gout, which could mean peak sales of $400 million.
Novartis shares were up 0.8 percent at 53.65 Swiss francs at 0906 GMT, when the DJ Stoxx European pharmaceuticals sector index .SXDP was 0.3 percent firmer.
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. (Reporting by Emma Thomasson; Editing by Greg Mahlich)