BRIEF—Ono Pharma submits marketing approval of metyrosine in Japan

Japanese drugmaker Ono Pharmaceutical has submitted a new drug application for the approval of pheochromocytoma (PCC) treatment metyrosine (ONO-5371), a tyrosine hydroxylase inhibitor licensed from Canada’s Valeant Pharmaceuticals International in October 2013, in Japan.

This application is based on a multicenter, open-label, non-comparative study and its accompanying continuous administration study, Phase I/II study (ONO-5371-02), in patients with the symptoms associated with catecholamine excess secretion of pheochromocytoma, conducted in Japan.

Valeant markets metyrosine under the trade name of Demser in the indication of PCC.