Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN).
Otsuka America Pharmaceutical, Inc., (OAPI) and Otsuka Pharmaceutical, Co., Ltd. (Otsuka) announce that the U.S. Food and Drug Administration (FDA) plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to seek input on issues related to the Supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).
Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck LLC today announced that the full results of a Phase 3 trial of brexpiprazole in combination with sertraline for the treatment of PTSD in adults have been published in JAMA Psychiatry.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646).
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.