Bukwang Pharmaceutical's Schizophrenia Treatment 'Latuda' Approved in Korea

The Ministry of Food and Drug Safety announced on the 23rd that it has approved Bukwang Pharmaceutical's new drug for the treatment of Major Depressive Episode related to schizophrenia and type 1 bipolar disorder, 'Latuda Tablets (Lurasidone Hydrochloride).' Major Depressive Episode refers to a period during which depressive symptoms appear without interest or pleasure in daily life.

Headquarters of Bukwang Pharmaceutical in Dongjak-gu, Seoul [Photo by Bukwang Pharmaceutical]

Latuda Tablets are administered once daily and work by binding to dopamine and serotonin receptors in the central nervous system, blocking the action of neurotransmitters in the brain to improve symptoms of schizophrenia and bipolar depressive disorder. Blocking dopamine receptors suppresses the excessive action of dopamine, effectively treating positive symptoms (such as hallucinations and delusions), while blocking serotonin receptors increases dopamine release in areas with dopamine deficiency, effectively treating negative symptoms (such as blunted emotions and illogical thinking).

Latuda Tablets are a new drug developed by Sumitomo Pharma, and Bukwang Pharmaceutical secured exclusive development and sales rights in Korea in April 2017, subsequently applying for product approval last October. In this approval, a total of five dosages?20, 40, 60, 80, and 120 mg?were approved simultaneously. Bukwang Pharmaceutical plans to proceed with decisions on health insurance coverage and drug price negotiations aiming for a launch next year. Growth Research analyzed that "after the drug price is finalized, sales of up to 40 to 50 billion KRW are expected."

Notably, Latuda Tablets have been approved for use in children and adolescents aged 10 and older, as well as adults. The Ministry of Food and Drug Safety stated, “Schizophrenia is approved for adolescents aged 13 and older and adults, and type 1 bipolar disorder is approved for children aged 10 and older and adults. Latuda Tablets have already been approved overseas in 53 countries for adult schizophrenia and in 20 countries for type 1 bipolar disorder, and have also been approved in some countries for adolescent schizophrenia and pediatric bipolar disorder treatment.”