Akebia Therapeutics, Inc. and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

Amidst COVID-19, Mental Health Leaders, Policymakers Explore Innovations and Policy Solutions to Strengthen Access to Care for People Living with Serious Mental Illness

WASHINGTON, DC – May 12, 2021 – Otsuka America Pharmaceutical, Inc. (Otsuka), a global leader in developing solutions to meet unmet mental health needs, today hosted its third-annual Advancing Mental Health Policy: BetterTogether Forum. This live, virtual event brought together more than 300 elected officials, thought leaders and stakeholders from across the mental health community to discuss the impact of COVID-19 on people living with mental illness and policies for strengthening equitable access to behavioral health care.

Otsuka Pharmaceutical Co., Ltd. announces that its collaborator Akebia Therapeutics, Inc. has submitted a New Drug Application to the Food and Drug Administration in the U.S. seeking approval for Akebia’s investigational drug vadadustat as an oral medication for the treatment of renal anemia due to chronic kidney disease in adult patients who receive dialysis and those who do not receive dialysis.

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S 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.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Click Therapeutics, Inc. announce the initiation of the Mirai study, a landmark fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with major depressive disorder (MDD) who are on antidepressant monotherapy.

The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, announces it has entered a collaboration agreement with Eikonizo Therapeutics, Inc., a biotechnology company committed to creating life-changing therapies, to develop inhibitors of histone deacetylase-6 (HDAC6) focused on treating amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease, and other diseases.

Otsuka Pharmaceutical Development & Commercialization, Inc., and Spencer Health Solutions, Inc., today announced an agreement to jointly create a transformational patient experience using the spencer® smart hub, the world’s first at-home medication device that connects patients and their care teams through an easy-to-use, fully integrated platform.

Otsuka US Political Action Committee (PAC) has a long history of providing financial support to legislators from both major U.S. political parties. Our PAC regularly reviews our giving strategy to ensure it is aligned with our corporate values, key policy issues that impact the patient communities we serve and our employees.

Conditions are ripe for transforming the U.S. mental health care system, with scientific advances, the growth of Medicaid, and political consensus on the importance of improving mental health creating the possibility that goals once thought out of reach may be possible, according to a new RAND Corporation study.