Otsuka/Lundbeck Closer To Adding Alzheimer’s Agitation To Rexulti Label
With no currently approved treatment for agitation in Alzheimer’s disease, analysts see a solid revenue opportunity for Rexulti. The companies plan to file a supplemental NDA later this year.
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Otsuka and Lundbeck are seeking to expand the use of psychiatry drug Rexulti into Alzheimer's agitation to up the product's commercial prospects, but mixed Phase III data for the drug mean a third regulatory nod is uncertain.
The private company may be behind the leaders, but with a long-term plan and a strategy of coming in with complementary therapies like the 5-HT6 receptor antagonist idalopirdine and the dopamine antagonist Rexulti (brexpiprazole), it could be a stable player in Alzheimer's.
The FDA late on 10 July approved Otsuka's and Lundbeck's new drug application (NDA) to market Rexulti (brexpiprazole), an atypical antipsychotic, as adjunctive treatment for adults with major depressive disorder (MDD), which affects about 15 million adults in the US, and as a treatment for adults with schizophrenia, which affects about 2.4 million American adults.