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FDA to ARNA: OK, We'll Look At Lorcaserin Data Without Diabetics

|Includes: Arena Pharmaceuticals, Inc. (ARNA), OREX, VVUS

The FDA has accepted for review Arena Pharmaceuticals' (NASDAQ:ARNA) application (NDA) for its flagship obesity drug lorcaserin, Arena said Wednesday.  The main significance of this is that the FDA has apparently agreed to review Arena's data without waiting for data from its slow-enrolling clinical trials on diabetic patients.

Arena expects the FDA to inform it in a few weeks of its PDUFA date, or deadline for the FDA's decision whether to approve lorcaserin.  This is supposed to be ten months out, but as we've noted before, in recent years has often slipped. 

As a reminder, Arena submitted its NDA on December 22, 2009, and competitor Vivus (NASDAQ:VVUS) a week later on December 29 for its drug Qnexa.  Orexigen Therapeutics (NASDAQ:OREX) also is preparing an application for Contrave to be submitted in the first half of this year.  Vivus's and Orexigen's applications are both expected to include data from their completed trials on diabetic patients.


Disclosure: Long ARNA, VVUS, OREX