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

Click here to read full press release/ article | Ref: Sumitomo Dainippon | Image: Doug Lipp