OTSKF - Otsuka Lundbeck get FDA Adcom meeting for Rexulti for Alzheimer's agitation
2023-03-29 17:43:48 ET
- The US FDA has scheduled an advisory committee meeting to evaluate an application from Otsuka ( OTCPK:OTSKF ) and H. Lundbeck ( OTCPK:HLBBF ) to expand the indication for Rexulti (brexipiprazole) to include Alzheimer's disease agitation.
- The Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee will jointly meet on April 14 .
- The FDA action date is May 10. Rexulti in the agtiation indication has Priority Review status.
- Otsuka ( OTCPK:OTSKY ) and H. Lundbeck ( OTCPK:HLUBF ) have previously stated that if approved, Rexulti would be the first therapy for agitation in Alzheimer's dementia .
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Otsuka, Lundbeck get FDA Adcom meeting for Rexulti for Alzheimer's agitation