Bukwang Pharm applies for approval of 'Lurasidone' for schizophrenia and bipolar depression treatment

[Asia Economy Reporter Chunhee Lee] Bukwang Pharmaceutical announced on the 31st that it has applied for domestic marketing authorization of the new drug for schizophrenia and bipolar depression treatment, ‘Lurasidone,’ to the Ministry of Food and Drug Safety.

Lurasidone is an atypical antipsychotic drug developed by Japan’s Sumitomo Pharma, approved for the treatment of schizophrenia and bipolar disorder depression. Bukwang Pharmaceutical holds exclusive development and distribution rights in South Korea.

Bukwang Pharmaceutical recently announced top-line results from a Phase 3 clinical trial comparing Lurasidone with the existing schizophrenia treatment ‘Quetiapine’ in patients with schizophrenia, confirming statistical significance for non-inferiority.

The company explained, “Lurasidone has advantages in improving patients’ social life and quality of life due to lower metabolic adverse reactions such as weight gain, increased prolactin, dyslipidemia, and hyperglycemia compared to existing atypical antipsychotics. It is also an atypical antipsychotic drug used as a treatment for bipolar disorder depression, for which drug options are very limited.”

Lurasidone is an antagonist that blocks dopamine D2, serotonin 5-HT2A, and 5-HT7 receptors. It also partially acts on serotonin 5-HT1A receptors and shows little affinity for histamine H1 and muscarinic M1 receptors.

Currently, it has obtained approval for schizophrenia and bipolar depression indications in more than 45 countries including the United States and the European Union (EU). It is a blockbuster product generating sales of approximately 2.6 trillion KRW in the North American market alone.

A Bukwang Pharmaceutical official said, “We expect Lurasidone to improve patients’ quality of life with proven therapeutic effects and safety for schizophrenia and bipolar disorder depression. We plan to make further efforts to strengthen the portfolio of central nervous system (CNS) products and achieve a leap in sales.”

This content was produced with the assistance of AI translation services.