Arena Reloads for Round 2 with FDA, With More Data on Weight Loss Drug in Diabetes Patients

11/9/10Follow @xconomy

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an A1c score of 7.0, according to the American Diabetes Association guidelines.

Nothing really surprising stands out about the new set of data on weight loss for lorcaserin patients. A little more than one-third (37.5 percent) of patients on a twice-daily dose of the treatment lost at least 5 percent of their body weight after a year, which was more than double the rate of people who did that well on placebo (16.1 percent), Arena said.

While that satisfies one of the FDA’s standards for effectiveness in a weight loss drug, Arena once again showed that not every individual responds so well to the treatment. The median person in the trial lost 10.3 pounds (4.5 percent of body weight) after a year, compared with 3.5 pounds (1.5 percent of body weight) for those who got a placebo. The FDA has said it likes to see a new weight loss drug beat placebo by at least 5 percentage points on median weight loss, and lorcaserin in this case, only showed it was about 3 percentage points better—a consistent finding with the earlier studies of 7,000 patients.

As Lief points out, the FDA has said in its written guidelines that an obesity drug only needs to clear one of the two thresholds, but then again, the FDA did say lorcaserin offered “marginal” benefit on effectiveness. And today’s Bloom-DM result doesn’t appear on the surface to change the picture very much.

Still, Lief found reason for optimism in what the drug appeared to do for the symptoms of diabetes. Patients on lorcaserin had, on average, a 0.9 percentage point reduction in their hemoglobin A1c scores, which brought the average score down to 7.1—right on the edge of normal according to the American Diabetes Association’s guidelines. Half of the patients on the Arena treatment were able to reach the ADA blood sugar control goals.

“That’s a big deal,” Lief says.

About 8.6 percent of patients on the Arena drug dropped out … Next Page »

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