Sumitomo Dainippon's Latuda (lurasidone HCl) Receives NMPA's (CFDA) Approval for Schizophrenia
Shots:
- The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia
- The study results: PANSS @6weeks (-19.3 vs -12.7); AEs (47.0% vs 51.1%); discontinued patients (5.7% vs 6.4%); improvement in CGI-S @6 weeks; well tolerated in patients
- Lurasidone (40/80 mg/day; flexible dose) is an antipsychotic candidate with antagonist effects for D2-5-HT2A and 5-HT7 receptors- and has received approval from the US in 2010- Canada in 2012- Switzerland in 2012- EU and Australia IN 2014 with awaited Japan approval in H1’19 for Schizophrenia
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