Arena Pharmaceuticals, Inc. (ARNA)

[PennyMaster1]

they met the second endpoint here is a copy and paste from another MB.

From EMEA guidelines:
"4.2.1 Primary endpoints
Weight loss is the primary endpoint. Demonstration of a clinically significant degree of weight loss of
at least 10% of baseline weight, which is also at least 5% greater than that associated with placebo, is
considered to be a valid primary efficacy criterion in clinical trials evaluating new anti-obesity drugs.
Proportions of responders in the various treatment arms could be considered as an alternative primary
efficacy criterion where response is more than 10% weight loss at the end of a 12-month period."

From the Meta Analysis of BLOOM, BLOSSOM, & BLOOM-DM:

"At one year, using Modified Intent-to-Treat with Last Observation Carried Forward analysis (MITT-LOCF) of the integrated results...22.0% of lorcaserin 10 mg BID patients and 17.3% of lorcaserin 10 mg QD patients achieved at least 10% weight loss, compared to 8.3% of patients on placebo."

So, both Lorc QD and BID 10% weight loss are > 5% difference from Placebo (BID: 22.0% - 8.3% = 13.7% QD: 17.3% - 8.3% = 9.0%). I don't see any mention of the % of patients that need to achieve 10% weight loss. All it says is "clinically significant degree of weight loss". Not sure why this is an issue...seems like Lorc clearly meets the EMEA guidelines.