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NEWS

10/24

New Report Reveals U.S. Family Caregivers Perform Equivalent of a Staggering $873.5 Billion Worth of Labor, Would Surpass Revenue of Top Global Companies

Findings released today from a new valuation study conducted by Columbia University Mailman School of Public Health, and sponsored by Otsuka America Pharmaceutical, Inc. reveal that if family caregiving was a business entity it would be the largest revenue-generating company in the world

10/22

Otsuka Announces Positive Interim Results from the Phase 3 Trial of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy in Adults

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. today announce positive topline interim data from the ongoing Phase 3 clinical trial of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults.

10/14

New Study Finds Family Caregivers Would Earn Six Figures If Paid A Salary

Findings released from a new compensation study, conducted by Salary.com and sponsored by Otsuka America Pharmaceutical, Inc. (Otsuka), reveal caregivers of loved ones with Alzheimer's or other dementias would earn a six-figure salary—approximately $114,000 on average—if paid for the daily care they provide.  

10/08

Mental Health America and Otsuka Collaborate to Address Mental Health Inequities in New Jersey Communities

Mental Health America, with support from Otsuka America Pharmaceutical, Inc., announces the launch of a new Equity Impact Zone (EIZ) grant program designed to address mental health equity gaps within local New Jersey communities.

07/31

Otsuka and Lundbeck Present New REXULTI® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2024

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC presented new post hoc pooled analyses of Phase 3 trials evaluating the safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer’s disease. These data analyses were presented in three posters at the 2024 Alzheimer’s Association International Conference (AAIC), taking place July 28 to Aug. 2 in Philadelphia, USA.

06/25

Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)

Otsuka Pharmaceutical, Co. Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

05/28

Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC presented results from the Phase II (Trial 061) and Phase III trials (Trial 071 and 072) evaluating the safety and efficacy of brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder. The findings were presented at the American Society of Clinical Psychopharmacology Annual Meeting in Miami.

05/22

Otsuka to Terminate Development of AVP-786

Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. announce termination of development of the novel compound AVP-786, which was in development as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease. 

05/15

Meharry School of Global Health Releases Landmark Report Showing Mental Health Inequities in the U.S. Could Cost an Estimated $14 Trillion by 2040

The School of Global Health at Meharry Medical College (Meharry) with support from Otsuka America Pharmaceutical, Inc., today released The Projected Costs and Economic Impact of Mental Health Inequities in the United States report. Findings show, that if not addressed, mental health inequities combined with expenditures related to chronic conditions, could cost the U.S. economy an estimated $14 trillion between now and 2040.

05/09

Otsuka Becomes Lead Founding Sponsor of PBS and WETA’s New Caregiving Documentary, Executive Produced by Bradley Cooper

Otsuka America Pharmaceutical, Inc., announces that the company is the lead, founding sponsor of Caregiving, a two-hour documentary dedicated to portraying the challenges and triumphs of caregivers through their personal stories. The project, executive produced by Bradley Cooper, is slated for release in Spring 2025 and is the next feature film of WETA’s award-winning Well Beings campaign that addresses critical health needs in America.

04/10

Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.

04/04

Otsuka Works with Verily to Launch Longitudinal Mental Health Registry to Advance Novel Research in Psychiatry

Otsuka Pharmaceutical Development & Commercialization, Inc. announces the launch of My Mental Health Journey, a longitudinal registry study that aims to advance research in depression and mental health. Verily Life Sciences LLC (Verily), a precision health technology company, will recruit participants and run the study. 

04/01

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the U.S. Food and Drug Administration  has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms.

03/21

Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment

Otsuka announces that interim data from a Phase 2b/c trial exploring quabodepistat (QBS), in combination with delamanid and bedaquiline, for the treatment of pulmonary tuberculosis (TB) is positive and may shorten the duration of TB treatment for patients. QBS is an investigational anti-tuberculosis compound which has a new mechanism of action that interferes with the cell-wall structure of the bacteria causing TB.

03/18

Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck U.S., the U.S. subsidiaries of H. Lundbeck A/S,  presented new post hoc pooled analyses of two pivotal Phase 3 trials evaluating the safety and efficacy of REXULTI® (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer’s disease.1 The posters were presented on March 16  at the American Association for Geriatric Psychiatry (AAGP) 2024 Annual Meeting in Atlanta.

03/15

Otsuka and Sumitomo Revise License Agreement

Otsuka Pharmaceutical Co., Ltd. announces the revision of the license agreement signed in September 2021 with Sumitomo Pharma Co., Ltd. and its U.S. subsidiary, Sumitomo Pharma America, Inc.

02/16

Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy

Otsuka Pharmaceutical Development & Commercialization, Inc., Otsuka Pharmaceutical, Co. Ltd., and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease).

02/12

Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated With Dementia Due to Alzheimer’s Disease

Otsuka Pharmaceutical Development & Commercialization, Inc., and our parent company Otsuka Pharmaceutical, Co. Ltd. announce topline results of the phase 3 clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520).