Otsuka Pharmaceutical Europe Ltd

Dawnzera (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema

Donidalorsen is a first-in-class RNA-targeted prophylactic therapy for patients with hereditary angioedema (HAE) Donidalorsen demonstrated a significant reduction in HAE attack rate compared with placebo in the Phase 3 OASIS-HAE study HAE is a rare and potentially life-threatening genetic condition affecting approximately 15,000 people in Europe. 21 January 2026 -- Windsor, UK -- Otsuka Pharmaceutical...

Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older

Brexpiprazole’s indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older Approval follows a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency in January 2025 Treatment with brexpiprazole (2-4 mg/day) significantly reduced the symptoms of schizophrenia as measured by PANSS...

Otsuka and Ionis enter into licensing agreement covering Europe for hereditary angioedema

19 December 2024 – London, UK – Otsuka Pharmaceutical Europe Ltd. (Otsuka) today announces that its parent company Otsuka Pharmaceutical Co., Ltd. and Ionis Pharmaceuticals, Inc. (Ionis), a leader in RNA-targeted therapy based in California, have entered into a licence agreement for Otsuka to acquire exclusive marketing rights to the Ionis hereditary angioedema (HAE) drug...

European Medicines Agency Commences Review of Aripiprazole 2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole

LONDON, UK, 17 June 2022 - Otsuka Pharmaceutical Europe Ltd. ('Otsuka') and H. Lundbeck A/S ('Lundbeck') today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.
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