Despite potential REMS hurdles, Arena's lorcaserin could fill niche in obesity
If FDA follows the advice of its advisory committee and approves Arena Pharmaceuticals Inc.'s lorcaserin, the biotech may be able to carve out a niche for the obesity compound despite modest efficacy and potential hurdles to use, including advice that recurring echocardiograms be used to rule out a cardiovascular risk.
Last week, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 18-4 with one abstention that the benefit-risk profile for lorcaserin supports approval for obesity.
The vote is a reversal from a September 2010 panel that voted 9-5 against approval due to lackluster efficacy and concerns about carcinogenicity and heart valve effects (see BioCentury, Sept. 20, 2010).
This time around, Arena was able to assuage the panel's concerns over the cancer signal with a mix of preclinical studies and readjudicated data.
The company also presented additional efficacy data in diabetic patients that showed a statistically significant effect on HbA1c.
However, the overall effect of lorcaserin on weight loss remained modest, and most panel members who voted yes voiced disappointment about the placebo-adjusted weight loss of only 3.3% in the Phase III program.
"I voted yes, but not with a lot of enthusiasm," said permanent voting member Erica Brittain. "I'm not happy with the modest treatment effect."
Brittain is a statistician at NIH's National Institute of Allergy and Infectious Diseases (NIAID).
The committee also had lingering concerns about the potential for lorcaserin to cause valvular heart disease (VHD), but members who supported concluded Arena could address the issue with a REMS and a postapproval cardiovascular outcomes trial.
Arena said it has not designed a REMS and FDA has not yet requested one. If the agency requires a REMS, it is unlikely that Arena could get one fleshed out and reviewed in the six weeks to lorcaserin's June 27 PDUFA date.