Novartis' Odomzo gets positive EMA/CHMP opinion

28 June 2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorization for Swiss pharma giant Novartis’ (NOVN: VX) Odomzo (sonidegib), intended for the treatment of adults with locally advanced basal cell carcinoma (BCC).

Odomzo will be available as 200mg hard capsules. Sonidegib inhibits the Hedgehog pathway, a key regulator of development and morphogenesis in mammals, which is linked to the pathogenesis of several cancers including BCC.

Novartis has also filed for approval of the drug in Australia, Switzerland and the USA.

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