Bukwang Pharmaceutical announced the approval of LATUDA (lurasidone hydrochloride) in Korea on 23th November, a new drug for the treatment of schizophrenia and depressive episodes associated with bipolar I disorder (bipolar I depression). According to the approved product information, LATUDA will be used for the treatment of schizophrenia in adults and adolescents 13 years of age and older and it is now approved to treat depressive episodes associated with bipolar I disorder in adults as monotherapy or as adjunctive therapy with lithium or valproate and pediatric patients 10 years of age and older as monotherapy. In September this year, Bukwang Pharmaceutical applied for insurance coverage as the Ministry of Food and Drug Safety completed the safety and efficacy review of LATUDA. Once the Health Insurance Review and Assessment Service completes the evaluation of medical care benefits, the final coverage and drug price will be determined through drug price negotiations with the National Health Insurance Service. LATUDA is an atypical antipsychotic agent used to treat schizophrenia and bipolar I depression that was originally discovered by Sumitomo Pharma Co., Ltd. Bukwang Pharmaceutical has the exclusive development and commercialization rights to LATUDA in Korea. LATUDA acts as an antagonist at dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors. In addition, LATUDA is a partial agonist of serotonin 5-HT1A receptors and shows little affinity for histamine H1 and muscarinic M1 receptors. According to Bukwang Pharmaceutical, LATUDA is approved for the treatment of schizophrenia in adults in 53 countries and regions including the United States (U.S.) and the European Union (EU) countries and for the treatment of adolescents (13 -17 years) in several countries. LATUDA is also approved for the treatment of bipolar I depression in adults as monotherapy or as adjunctive therapy with lithium or valproate in 20 countries and regions including the U.S., and for the treatment of children and teens (10 to 17 years) as monotherapy in several countries. “We are very pleased to offer a new treatment option for people living with schizophrenia and bipolar I depression with the approval of LATUDA,” and “LATUDA is a blockbuster product with huge sales potential of multi-billion won in annual sales, strengthening our CNS portfolio and driving future revenue growth for Bukwang Pharmaceuticals," said an official from Bukwang.
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