Articles from Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today 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). APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home.

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck LLC (Lundbeck) 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. The results showed that in adults with PTSD, treatment with brexpiprazole in combination with sertraline resulted in statistically significant greater improvement of PTSD symptoms vs treatment with sertraline plus placebo, as measured by change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from Week 1 to Week 10.1

Findings released today from a new valuation study conducted by Columbia University Mailman School of Public Health, and sponsored by Otsuka America Pharmaceutical, Inc. (Otsuka), reveal that if family caregiving was a business entity it would be the largest revenue-generating company in the world — exceeding the revenue of Apple (+126%), Amazon (+45%) and Walmart (+31%). The report, “America’s Unseen Workforce: What Will it Take to Change the Future of Family Caregiving?” is the latest installment of a caregiver research series from Otsuka.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka), 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.

Barbara Corcoran, renowned entrepreneur, author, investor and caregiving advocate, is collaborating with Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck LLC (Lundbeck) to introduce ‘I Wish I Knew,’ a national public education campaign. Announced today, the campaign is aimed at helping over 11 million family caregivers of people with Alzheimer’s dementia better understand the signs and symptoms of agitation in Alzheimer’s dementia, a separate condition that nearly half of people living with Alzheimer’s dementia show signs of but that many people don’t know exists.1-3 Barbara is sharing her family’s difficult journey in hopes that others will benefit from what she wishes she knew when her own mother was diagnosed with Alzheimer’s disease and was showing symptoms of agitation in Alzheimer’s dementia. Agitation in Alzheimer’s dementia is one of the most persistent and distressing behavioral conditions that can cause patients to act out in uncharacteristic ways like verbal aggression, physical aggression, and restlessness.3-4

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) 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.1-3 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.1-3

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) today 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 (PTSD).1,2 The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) 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.

Otsuka Pharmaceutical Development & Commercialization, Inc., and our parent company Otsuka Pharmaceutical, Co. Ltd., announce 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.1,2 Worldwide, TB is the second leading infectious fatal disease after COVID-19.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck U.S., the U.S. subsidiaries of H. Lundbeck A/S, (Lundbeck) 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.

Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) and our parent company Otsuka Pharmaceutical, Co. Ltd. (Otsuka) 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). A statistically significant difference was not achieved on the primary efficacy endpoint, mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo.

Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., today announced positive results of two, 6-week, Phase 3 clinical trials that evaluated the efficacy, safety, and tolerability of centanafadine for the treatment of adolescents and children with attention-deficit/hyperactivity disorder (ADHD). Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor.

Otsuka Pharmaceutical Co., Ltd (Otsuka) and H. Lundbeck A/S (Lundbeck) published results from research demonstrating that an investigational long-acting injectable, aripiprazole 2-month, ready-to-use 960 mg, offers comparable tolerability, safety and therapeutic plasma levels as aripiprazole 1-month, ready-to-use 400 mg, currently approved in adult patients for the treatment of schizophrenia or the maintenance treatment of bipolar I disorder (BP-I). The research is published in CNS Drugs.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce positive results of the Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia (NCT03548584). The analysis concluded that there is a statistically significant difference (p=0.0026) in the mean change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo.

The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. (Mindset) (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) today announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) report that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti® (brexpiprazole) and has granted Otsuka and Lundbeck Priority Review. Up to one-third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the U.S. for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults.

The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, announces today the launch of Otsuka’s Digital Pioneer Initiative (ODPI). The ODPI was created to accelerate Otsuka’s digital health capabilities through active and strategic engagement with early-stage companies focused on improving mental health and well-being. MSRD also announced a strategic investment in Mindful Mamas—a digital solution for maternal and family mental wellness.

The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, announces today that it has entered an agreement with Sentinel Oncology (Sentinel), a drug discovery company.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type (NCT03548584). The decision to continue the trial is based on the results of an independent interim analysis, supporting to progress the trial to the planned full enrollment of 330 patients.