updated 7/31/2009 7:18:24 PM ET 2009-07-31T23:18:24

Federal health regulators on Friday approved a potential blockbuster diabetes drug from Bristol-Myers Squibb Co. and partner Astrazeneca PLC.

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

The Food and Drug Administration said it approved the companies' drug Onglyza to reduce blood sugar levels in patients with type 2 diabetes, which affects 24 million people in the U.S.

The drug is part of a new wave of medications taking aim at the U.S. diabetes market, which has grown to more than $5 billion as the disease becomes more prevalent.

Onglyza's chemical makeup is similar to Merck's Januvia, which had blockbuster sales of $1.4 billion last year.

Analyst estimates of Onglyza's market potential vary, given its similarity to a more established drug. Sales estimates range from $300 million per year to more than $1 billion.

The drug is the first to gain approval since the agency issued new testing guidelines for diabetes treatments last year. Concerns about heightened risks of heart attack with GlaxoSmithKline's pill Avandia created a storm of controversy around the FDA and the safety standards for popular diabetes treatments.

Data from eight clinical trials conducted by New York-based Bristol-Myers and Anglo-Swedish AstraZeneca did not show evidence of higher rates of heart attack, stroke and other problems. Despite such evidence, the FDA said it will require the companies to conduct a follow-up study examining those problems in high-risk patients, including the elderly and those with existing heart conditions.

People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Discussion comments


Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments