FDA nod for Rexulti sNDA in treatment of Alzheimer's agitation

Following a positive vote last month from the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee, the US Food and Drug Administration (FDA) has now approved the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.

Rexulti is being developed by discoverer Japan’s Otsuka (TYO: 4578) and Denmark’s Lundbeck (LUND: CO), whose shares moved up 2.5% to 35.46 kroner on the news. Otsuka’s stock was barely moved by the development.

SVB Securities Research analyst Marc Goodman has previously said AAD is an interesting opportunity for Rexulti, that could contribute $500 million in additional sales over the next five or six years. Also marketed under the trade name Rxulti, and originally approved in the USA in July 2015 as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults, the drug generated sales of 3,890 million kroner ($572 million) for Lundbeck in 2022.