Bukwang Pharmaceutical said that the Ministry of Food and Drug Safety has approved Latuda Tab. (ingredient: Lurasidone Hydrochloride), a treatment for schizophrenia and major depressive episodes associated with bipolar I disorder developed by Japan's Sumitomo Pharma.

Latuda acts as an antagonist by blocking dopamine D2, serotonin 5-HT2A, and 5-HT7 receptors, while partially acting on the serotonin 5-HT1A receptor and showing almost no affinity for histamine H1 and muscarinic M1 receptors.

According to the approved domestic authorization, Latuda can be used for schizophrenia in adolescents (aged 13 and older) and adults, and as a monotherapy or as an adjunctive therapy with lithium or valproate for major depressive episodes associated with bipolar I disorder in adults, and as monotherapy for children (aged 10 and over).

According to Bukwang, Latuda has been approved as an adult schizophrenia treatment in 53 countries, including the U.S. and EU, and in 20 countries as a monotherapy or adjunctive therapy with lithium or valproate for adult bipolar I depression.

The company is also in the process of receiving reimbursement for the drug after completing the safety and efficacy review by the MFDS in September.

"We are very pleased to be able to offer a new treatment option to patients with schizophrenia and bipolar I depression with the approval of Latuda," a company official said. "We expect that the treatment will become a blockbuster product, strengthen our central nervous system (CNS) portfolio, and lead to future sales growth for the company."