Dainippon submits atypical antpsychotic NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Dainippon Sumitomo submitted an NDA for its atypical antipsychotic lurasidone for schizophrenia, and the company likely is hoping its newly acquired Sepracor sales force is up to the challenge in a crowded, but still fruitful, market (1"The Pink Sheet" DAILY, Jan. 6, 2009). Dainippon Sumitomo Pharma America submitted the NDA Dec. 30, ahead of initial plans to file in the third quarter of 2010. The company attributes the earlier submission date to the positive results, and particularly the safety profile, established in two Phase III PEARL studies. PEARL 2 results released Aug. 26 showed lurasidone at both 40 mg/day and 120 mg/day to be significantly more effective than placebo. In a Sept. 3 call to discuss the Sepracor acquisition, Dainippon Sumitomo CEO Masayo Tada touted lurasidone's effect on weight gain compared to placebo and Lilly's Zyprexa (olanzapine), which was included in an active-comparator arm to establish assay sensitivity. Although the atypical antipsychotics are a mature class, side effect profiles and frequent switching mean there is still room on the market, and the field saw two newcomers in 2009, Vanda's Fanapt and Schering-Plough's (now Merck's) Saphris