In an already saturated psychiatry market, how will Otsuka and Lundbeck’s new antipsychotic drug perform?
The US FDA has accepted Lundbeck and Otsuka’s simultaneous schizophrenia and depression NDAs for review, setting a PDUFA date for 11 July, 2015.
The companies have previously disclosed positive Phase III data supporting the drug’s use as an adjunctive therapy for major depressive disorder, although little is known about the pivotal schizophrenia trials. Brexpiprazole appears to have a greater association with weight gain than the companies’ market-leading, $8bn-antipsychotic brand, Abilify. This side-effect profile, combined with the entrance of Abilify generics ahead of the FDA’s 2015 action date, both serve to greatly limit brexpiprazole’s commercial opportunity compared to its predecessor.
Datamonitor Healthcare forecasts that brexpiprazole will generate approximately $675m for schizophrenia and depression in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) by 2021. Sales in other markets, plus off-label use in other psychiatric conditions, may boost brexpiprazole to blockbuster sales, although this must represent a disappointment when compared to Abilify’s current market status.
Posted in Central Nervous System.