Bukwang Pharmaceutical receives product approval for ‘Latuda Tablet’, a new drug for the treatment of schizophrenia and type 1 bipolar depression

[이데일리 나은경 기자] On the 23rd, Bukwang Pharmaceutical (003000) received approval from the Ministry of Food and Drug Safety for its new drug ‘Latuda Tablet’ (ingredient name: lurasidone hydrochloride) for the treatment of major depressive episodes (type 1 bipolar depression) related to schizophrenia and bipolar type 1 disorder. It was announced on the 24th that the permit was approved. According to the domestic approval approved this time, Latuda tablets are used for schizophrenia in adolescents and adults over 13 years of age, and can be used as monotherapy or as adjunctive therapy with lithium or valproic acid for major depressive episodes related to type 1 bipolar disorder in adults. It is indicated as monotherapy for major depressive episodes associated with bipolar 1 disorder in children 10 years of age and older.

Bukwang Pharmaceutical applied for insurance benefit registration after the Ministry of Food and Drug Safety’s safety effectiveness review was completed last September. Once the evaluation of nursing care benefits is completed with the Health Insurance Review and Assessment Service, final reimbursement and drug prices are determined through drug price negotiations with the National Health Insurance Corporation.

Latuda Tablet is an atypical antipsychotic drug developed by Sumitomo Pharma in Japan and approved for the treatment of schizophrenia and bipolar type 1 depression. Bukwang Pharmaceutical has secured exclusive development and distribution rights in Korea.

Latuda tablets act as an antagonist that blocks dopamine D2, serotonin 5-HT2A and 5-HT7 receptors. It partially acts on the serotonin 5-HT1A receptor and shows little affinity for histamine H1 and muscarinic M1 receptors.

According to Bukwang Pharmaceutical, Latuda Tablet has been approved as a treatment for schizophrenia in adults in 53 countries, including the United States and European Union countries, and in some countries, it has also been approved as a treatment for schizophrenia in adolescents (13 to 17 years old). In 20 countries, including the United States, it has been approved as a monotherapy or adjuvant treatment with lithium or valproic acid for bipolar 1 depression in adults, and in some countries, it has been approved for bipolar 1 depression in children (10 to 17 years of age). It was also approved as a monotherapy.

Bukwang Pharmaceutical said, “With the approval of Latuda Tablet, we have been able to provide a new treatment option to patients with schizophrenia and type 1 bipolar depression.” “Ratuda Tablet is a large-scale product that can generate tens of billions of won in annual sales, and is a treatment for the central nervous system (CNS). ) In addition to strengthening the product portfolio, it will be a blockbuster product that will drive Bukwang Pharmaceutical’s sales growth in the future.”