FDA approves Rexulti for schizophrenia, MDD

FDA approved Rexulti brexpiprazole from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and H. Lundbeck A/S (CSE:LUN) to treat schizophrenia and as an adjunct treatment for major depressive disorder (MDD). The partners plan to launch Rexulti in early August. Lundbeck spokesperson Ashleigh Duchene declined to disclose the wholesale acquisition cost for Rexulti, a partial agonist of the dopamine D2 receptor with affinity for multiple serotonin receptors.

The drug's label includes a boxed warning describing an increased risk of death in elderly patients with dementia-related psychosis and an increased risk of suicidal thoughts and behaviors in patients aged 24 years and younger. ...