Back to top

Analyst Blog

AstraZeneca (AZN - Analyst Report) and partner Bristol-Myers Squibb Company (BMY - Analyst 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.

Our Take

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 - Analyst Report) and Vanda Pharmaceuticals, Inc. . Both carry a Zacks Rank #2 (Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
PLANAR SYST… PLNR 4.44 +5.21%
BITAUTO HOL… BITA 81.71 +5.12%
CTPARTNERS… CTP 16.66 +4.26%
CHINA BIOLO… CBPO 47.91 +3.30%
MALLINCKROD… MNK 72.94 +2.85%