Arena's lorcaserin to receive FDA review

SAN DIEGO Arena Pharmaceuticals obesity drug lorcaserin is expected to clear a key safety review this month, according to Reuters.

The drug blocks appetite signals in the brain. There have been concerns though that drug may have a fatal side effect, heart valve damage. Redux, lorcaserin’s parent drug manufactured by Wyeth was pulled off the market because it was linked to heart valve damage. But, the difference between the drugs is that Redux was hitting too many biological receptors on top of the one that reduces appetite.

Arena has been conducting a safety review of the drug in hopes of getting it approved by the Food and Drug Administration. The results of that year long review will be released some time this month and so far, at six months, there was no evidence of heart valve damages.

Arena has enrolled about 3,200 patients in the Phase 3 trial and will study them for two years. The safety board will review echocardiograms of patients again at 18 and 24 months, but the trial’s main goal is efficacy at 12 months, the period just ended, Arena chief executive Jack Lief said.

He said the study will conclude early next year and the company expects to file for regulatory approval of lorcaserin toward the end of 2009.