Arena Pharmaceuticals has submitted information on their one year study of LORQESS (lorcaserin) to the FDA to support their NDA application for the drug in treating obesity. We, as well as others have provided opinions on the likelihood of Arena being successful, the Advisory Committee did not recommend approval and the FDA has not approved LORQESS. Yet, Arena keeps trying.
The new one year data provide some additional information on the efficacy that still isn’t enough to convince me that the drug is at least meeting the minimum requirements of the FDA Guidelines for Obesity Drugs. I can’t even say that the results are marginal. At the end of a year, LORQESS patients showed a 4.5% weight loss from baseline compared to a 1.5% weight loss for placebo patients.
By far, the most alarming data in the one year study are the reports of study patients who showed heart valve problems. The LORQESS patient group reported 2.9% of patients with heart valve problems vs. only 0.5% reported for the placebo group.
Doesn’t anyone at Arena remember all the heart valve problems with diet drugs 10 years ago? C’mon, somebody take the shovel away from them – the hole is deep enough already!