Advertisement
U.S. markets open in 1 hour 21 minutes
  • S&P Futures

    5,067.75
    -13.25 (-0.26%)
     
  • Dow Futures

    38,872.00
    -121.00 (-0.31%)
     
  • Nasdaq Futures

    17,873.25
    -42.00 (-0.23%)
     
  • Russell 2000 Futures

    2,045.70
    +2.30 (+0.11%)
     
  • Crude Oil

    78.58
    +0.04 (+0.05%)
     
  • Gold

    2,038.40
    -4.30 (-0.21%)
     
  • Silver

    22.55
    -0.09 (-0.40%)
     
  • EUR/USD

    1.0828
    -0.0014 (-0.13%)
     
  • 10-Yr Bond

    4.2740
    0.0000 (0.00%)
     
  • Vix

    14.10
    +0.26 (+1.88%)
     
  • GBP/USD

    1.2639
    -0.0021 (-0.16%)
     
  • USD/JPY

    150.1400
    -0.4930 (-0.33%)
     
  • Bitcoin USD

    62,740.50
    +2,851.14 (+4.76%)
     
  • CMC Crypto 200

    885.54
    0.00 (0.00%)
     
  • FTSE 100

    7,650.96
    +25.98 (+0.34%)
     
  • Nikkei 225

    39,166.19
    -41.84 (-0.11%)
     

Japan's Otsuka Pharma-Lundbeck Partnered Depression Drug Gets FDA Approval For Alzheimer's Agitation

Otsuka Pharmaceutical Co Ltd (OTC: OTSKF) (OTC: OTSKY) (Otsuka) and H. Lundbeck A/S have received FDA approval for Rexulti (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer's disease.

This approval makes Rexulti the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer's disease.

It is reported in approximately half of people with Alzheimer's dementia and is associated with earlier nursing home placement.

Rexulti is not indicated as an as-needed (PRN) treatment for agitation associated with dementia due to Alzheimer's disease.

The submission was based on two Phase 3 studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer's disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score.

Overall, the data showed brexpiprazole as being well-tolerated with a low incidence of discontinuations and a safety profile consistent with the known safety profile of brexpiprazole in other indications.

Brexpiprazole was previously approved in the U.S. to treat adults with major depressive disorder and schizophrenia.

Photo by Gerd Altmann from Pixabay

 

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article Japan's Otsuka Pharma-Lundbeck Partnered Depression Drug Gets FDA Approval For Alzheimer's Agitation originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Advertisement