) recently received positive news when its arthritis drug Ilaris
was approved by the European Commission for an additional
The EC cleared Ilaris for the treatment of active systemic
juvenile idiopathic arthritis (SJIA) in patients aged 2 years and
above in the EU, who did not respond adequately to previous
therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and
The approval was based on positive results from two phase III
trials on SJIA patients aged between 2 and 19 wherein it was
observed that a majority of patients treated with Ilaris showed
significant improvement. The primary endpoints of both the
studies were met.
The EU approval of the Ilaris for the SJIA indication does not
surprise us as in Jul 2013, the Committee for Medicinal Products
for Human Use gave a positive opinion on the same. Ilaris
received approval for the SJIA indication in the U.S. in May
Ilaris is already approved in the U.S. and the EU for the
treatment of Cryopyrin-Associated Periodic Syndromes.
We remind investors that Ilaris was approved in Europe in Mar
2013 for treating patients with acute gouty arthritis who suffer
frequent attacks and their symptoms cannot be managed by the
available treatment options.
Meanwhile, Ilaris is also being studied for a number of rare
autoinflammatory conditions, including tumor necrosis factor
receptor-associated periodic syndrome, colchicine-resistant
familial mediterranean fever and hyper IgD syndrome.
Ilaris generated sales of $51 million in the first half of
2013, up 46% year over year. The recent approvals for additional
indications should boost sales further in our view.
We note that
) Actemra is also approved to treat SJIA in the US and EU.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) look attractive with a Zacks Rank #2 (Buy).
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