AstraZeneca (AZN - Free Report) and partner Bristol-Myers Squibb Company (BMY - Free Report) announced that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of approving metreleptin. The EMDAC recommended the approval of metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD).
The FDA’s advisory committee voted 11 to 1 that metreleptin’s benefit outweighs its risk for the treatment of pediatric and adult patients with generalized LD. However, the EMDAC voted against (2 to 10) the approval of metreleptin for the treatment of patients with metabolic disorders associated with partial LD.
The EMDAC recommendation was based on data from two pivotal open-label National Institutes of Health (NIH) studies and an additional open-label expanded access study - FHA101.
The candidate enjoys orphan drug designation in both the U.S. and Europe. A final decision from the FDA should be out by Feb 24, 2014.
We remind investors that Bristol-Myers and AstraZeneca have been collaborating since Jan 2007 for the development and commercialization of candidates for type II diabetes. In Aug 2012, Bristol-Myers purchased Amylin and expanded its partnership with AstraZeneca for developing and marketing Amylin's diabetes candidates/drugs including metreleptin.
We are disappointed with the EMDAC not recommending metreleptin for metabolic disorders associated with partial LD. We believe that approval of metreleptin for a narrower indication would limit the drug's sales potential. We note that although the FDA is not bound to accept the recommendation of the panel, it usually considers the same while deciding on the fate of a candidate.
Both AstraZeneca and Bristol-Myers carry a Zacks Rank #3 (Hold). Some better-ranked stocks include Bayer (BAYRY - Free Report) and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both carry a Zacks Rank #2 (Buy).