) recently announced that the US Food and Drug Administration
(FDA) has approved Ilaris (canakinumab) for an additional
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Ilaris is now approved for the treatment of active systemic
juvenile idiopathic arthritis (SJIA) in patients AGED 2 years and
above in the US.
The approval was based on encouraging data from two phase III
trials in SJIA patients (2 to 19 years) wherein a majority of
Ilaris-treated patients showed considerable improvement.
SJIA is the most severe type of juvenile idiopathic arthritis
(JIA). We note that Ilaris is already approved in the US for the
treatment of cryopyrin-associated periodic syndromes (CAPS).
Additionally, Novartis had filed for regulatory approval of
Ilaris in the EU and the US in 2011 for the treatment of patients
suffering from acute attacks of gout based on positive data from
two phase III registration studies. In Mar 2013, Ilaris was
approved by the EU for treating patients with acute gouty
arthritis who suffer frequent attacks and their symptoms cannot
be managed by the available treatment options.
However, the FDA approval is still pending for this indication.
In Aug 2011, Novartis received a Complete Response Letter (CRL)
from the US Food and Drug Administration asking for additional
information to evaluate the risk benefit profile in refractory
gout patients. Novartis continues to work with the FDA to
determine the next steps for llaris in the gout indication.
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 $24 million in the first quarter of
2013, up 54% year over year. The FDA approval for SJIA should
boost sales further in our view.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) look attractive. All three carry a Zacks Rank #1(Strong