BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Wednesday, February 18, 2026
See today's BioWorld
Home » Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation
To read the full story, subscribe or sign in.

Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation

April 12, 2023
By Randy Osborne
Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder.
BioWorld Regulatory Neurology/psychiatric FDA

Popular Stories

  • Today's news in brief

    BioWorld
  • Illustration of SCAN in Parkinson’s vs healthy subcortex

    SCAN is core circuit affected in Parkinson’s disease

    BioWorld Science
    Parkinson’s disease (PD) is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder,...
  • 3D illustration of skin layers

    TL1A is overexpressed in hidradenitis suppurativa

    BioWorld Science
    Despite the availability of advanced therapeutic options, about 40%-50% of patients with hidradenitis suppurativa do not achieve significant improvement in...
  • IL-22 and TL1A, a robust couple for diagnosing hidradenitis suppurativa

    BioWorld Science
    Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with strong association with psoriasis and inflammatory bowel disease (IBD). While some...
  • Illustration of head with maze that is missing parts

    Inhibiting the NLRP3 inflammasome for cognitive impairment, stroke

    BioWorld Science
    Vascular cognitive impairment and dementia (VCID) and cerebral small vessel disease are among the leading causes of dementia, where inflammation is known to play...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing