FDA approves Dainippon's Latuda for schizophrenia

The FDA has given the green light to Dainippon Sumitomo Pharma's Latuda (lurasidone), an atypical antipsychotic. The drug is designed to work like other atypcals such as Zyprexa, Risperdal or Seroquel, but without causing significant weight gain. The improved safety profile has lead analysts to predict that Latuda will break the coveted billion-dollar barrier in the U.S.

Last year Dainippon closed a deal to buy Sepracor for $2.6 billion. Among other assets, the Japanese company gained 1,200 pharma reps who have been gearing up for a major push as the company attempts to gain market share in the fiercely competitive antipsychotic market. The drug will be available in first quarter of 2011.

"Latuda marks both a significant achievement for our company as well as the first FDA approval for Sunovion since becoming the U.S. subsidiary of Dainippon Sumitomo Pharma" said CEO Masayo Tada. "With this approval, we've taken another big step towards becoming a truly competitive global company by enhancing the presence of Sunovion in the United States." The company is also testing lurasidone as a treatment for bipolar disorder.