Bukwang Pharmaceutical said it recently sought the local marketing approval for Lurasidone, a new drug for schizophrenia and bipolar depression developed by Japan's Sumitomo Pharmaceutical.

Bukwang has applied for product approval for  Lurasidone, a new drug for schizophrenia and bipolar depression, to the Ministry of Food and Drug Safety.
Bukwang has applied for product approval for Lurasidone, a new drug for schizophrenia and bipolar depression, to the Ministry of Food and Drug Safety.

The application follows Bukwang’s 2017 deal with Sumitomo to secure the drug's exclusive development and distribution rights.

Bukwang's recently confirmed the statistical significance of non-inferiority of Lurasidone, when compared with Quetiapine, an existing treatment for schizophrenia, in a top-line phase 3 clinical trial result.

According to Bukwang, Lurasidone has an advantage in improving the social life and quality of life of patients because it has lower metabolic adverse reactions such as weight gain, prolactin increase, dyslipidemia, and hyperglycemia, compared to existing atypical antipsychotics.

Also, it is an atypical antipsychotic drug that is used as a treatment for bipolar depression, a field left with few treatment options.

Lurasidone has obtained approval for schizophrenia and bipolar depression in more than 45 countries, including the U.S. and the EU, and is a blockbuster product with sales of about 2.6 trillion won ($1.8 billion) in the North American market.

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