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28 Sep 2011

Novartis Receives Japanese Regulatory Approval for Two Innovative Therapies

The Japanese regulators have approved Novartis' once-daily Gilenya (fingolimod) 0.5mg and Illaris (canakinumab) subcutaneous injection 150mg in the Japanese market.

Basel-based pharmaceutical and biotechnology corporation Novartis announced Tuesday that it received regulatory approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) for once-daily Gilenya (fingolimod) 0.5mg and for Illaris (canakinumab) subcutaneous injection 150mg.


Gilenya is used for the prevention of relapse and delay of progression of physical disability in adults with multiple sclerosis (MS) and Illaris is the first treatment for adults and children with cryopyrin-associated periodic syndrome (CAPS).


In the US, Gilenya is approved for relapsing forms of MS. In the EU, Gilenya is approved for people with highly active relapsing-remitting MS despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.


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