TAKEDA, Vortioxetine (Brintellix) – US Approval for MDD Likely in October – Competitive Enough Against Genericized MDD Market, Yet Maturing Late Stage Pipeline Candidates Warrant A Close Watch!

Date: 2015-07

Takeda’s late stage pipeline candidate – Vortioxetine (Filed, Partnered with Lundbeck, US PDUFA on October 2nd) is expected to get FDA approval for the treatment of Major Depressive Disorder (MDD). Despite the fact that antidepressant market will be ~fully genericized by 2013 (when Cymbalta will go off patent in Dec 2013), there are ~dozen of compounds in mid-late stage development for the treatment of MDD (Table-1). Increasing prevalence, high unmet need (poor tolerability, moderate efficacy, and thus switching as an unavoidable phenomenon among existing options), and treatment resistance create the need for newer options and still present an attractive market for new entrants. Reported PhIII data of Vortioxetine look………….. However, other pipeline candidates are chasing Vortioxetine very closely. PhIII data from

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