Arena and Eisai say new lorcaserin Ph III data show statistically significant weight loss

Arena Pharmaceuticals (Nasdaq: ARNA) and marketing partner Japanese drug major Eisai  demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes using its investigational weight loss drug lorcaserin.

The companies recently suffered a disappointment, when the USA Food and Drug Administration declined to approve the drug and called for submission of final data from the BLOOM-DM study )The Pharma Letter October 25). Arena is vying with Vivus’ racing Qnexa (phentermine/topiramate) - that has been rejected by the agency - and Orixigen’s Contrave (naltrexone SR/bupropion SR) - still awaiting a review in December - to get their drugs cleared for marketing by the FDA, which has not approved a new anti-obesity agent for more than a decade.

In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, lorcaserin patients taking lorcaserin 10mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.