) recently announced that the European Commission (EC) has
approved its drug llaris (canakinumab, ACZ885) for an additional
indication. The EC cleared llaris for treating adults suffering
from gouty arthritis (gout) - a serious, chronic and progressive
Patients experience attacks of gout when the body has a strong
inflammatory response to the uric acid crystals forming in the
affected joint. Moreover, the symptoms of such attacks cannot or
should not be managed with existing therapies.
Novartis stated in its press release that the approval of
Ilaris makes it the first biologic to be cleared in the EU for
symptomatic pain relief in a gouty arthritis indication. In
addition, Novartis has received an additional year of data
exclusivity from the EC, which was determined by the significant
clinical benefit that Ilaris provides over existing
The approval does not come as a surprise since in Jan 2013 the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) had recommended the approval of
Ilaris for the indication.
The EU approval was based on data from two phase III trials
and their extensions, which demonstrated that patients treated
with Ilaris experienced significantly greater pain relief
compared to the injectable steroid triamcinolone acetonideno.
We note that Ilaris is already approved for treating children
and adults suffering from cryopyrin associated periodic syndrome
(CAPS) in the EU, US, Switzerland and Japan.
However, the approval process in the US has been bumpy. In Aug
2011, Novartis received a Complete Response Letter (CRL) from the
US Food and Drug Administration (FDA) 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.
Novartis carries a Zacks Rank #3 (Hold). Pharma stocks, which
currently look attractive are
Eli Lilly & Co
) each carrying a Zacks Rank #2 (Buy).
LILLY ELI & CO (LLY): Free Stock Analysis
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