positive Phase III trial results; however, small difference in weight loss from placebo (3.6% difference) - not enough to impress investors or to get FDA approval(3/09); NDA expected to be filed by end of 2009; positive Phase III placebo-controlled data reported in 6/09: significant categorical/absolute weight loss in 1st year, with maintenance of weight loss in year 2; all primary endpoints met in one-year data reported in 9/09; pivotal BLOSSOM trial demonstrates that treatment over one year was associated with highly significant improvements for secondary endpoints (10/09); NDA filed 12/09 and accepted 2/10; PDUFA date 10/22/10; FDA advisory board scheduled for 9/16/10; Arena partners with Eisai (6/10)
Brand Lorqess Generic lorcaserin
Company name Arena, Eisai Product type Non-speciality
Therapeutic category CNS Key uses Obesity
Other Uses N/A Drug Class 5-HT2c agonist
Dosage From oral Expected Approval 2010-Q4
FDA Filing 12/09 Last Update date August 27,2010
Link to news article
Link to clinicaltrials.gov
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