Zacks_Analysts' Blog : Arena Pharma Files Response to CRL - Analyst Blog

Arena Pharmaceuticals, Inc. (ARNA) and partner Eisai Inc. recently announced that the former has responded to the FDA's complete response letter (CRL) for Arena Pharma’s weight loss candidate lorcaserin.

Story so far

In December 2009, Arena Pharma submitted the new drug application (NDA) to the FDA to get lorcaserin approved for weight management, including weight loss and its maintenance, in obese (Body Mass Index, or BMI, >30) or overweight (BMI >27) patients suffering from at least one weight-related co-morbid condition. The NDA was submitted by Arena Pharma on the basis of data from 18 studies that evaluated 8,576 patients.

The US agency, after reviewing the NDA, refused to approve lorcaserin in October 2010 citing tumor-related safety concerns. The FDA, while issuing the CRL, also stated that the efficacy of the drug in non type II diabetes obese patients was found to be marginal. The regulatory body also asked Arena Pharma to submit the final study report of the BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) study which evaluated lorcaserin for weight loss in patients suffering from type II diabetes.

Arena Pharma has submitted the requested additional data in its response to the CRL. It is expected that the US regulatory body will accept the response to the NDA by the end of January 2012 and assign a new target date by which it will come to a decision regarding lorcaserin.

Our take & recommendation

We believe that investor focus will be on the fate of lorcaserin going forward. We prefer to remain on the sidelines, with a ‘Neutral’ view on Arena Pharma, till more visibility is obtained on lorcaserin’s progress. The stock carries a Zacks #3 Rank (‘Hold’ rating) in the short run. Other companies that are working on gaining approval for their obesity candidates include Orexigen Therapeutics, Inc. (OREX) and Vivus Inc. (VVUS).