Sunday, September 11, 2005

New Diabetes Drug Gets FDA Panel Backing

Last Friday, the day after the FDA's Endocrinologic & Metabolic Drugs Advisory Committee endorsed the inhaled insulin ExuberaTM, it gave its nod to another new diabetes drug, PargluvaTM.

Unlike ExuberaTM, PargluvaTM (also known as muraglitazar) is not an insulin, nor is it inhaled. It is a new oral medication developed by Bristol-Myers Squibb and Merck for the treatment of type 2 diabetes.

PargluvaTM falls into the new class of diabetes drugs called glitizars. It is designed not only to lower blood glucose but to improve triglyceride and HDL (good cholesterol) levels as well.

The drug received endorsement in spite of:

  1. Questions of conflict-of-interest among panel members. (See New York Times story below.)

  2. Possible health risks. The non-profit group Public Citizen (see story below) is arguing against FDA approval of Pargluva based on risks, notably heart problems, uncovered during clinical trials.

Again, as with ExuberaTM, endorsement by an FDA panel does not assure final FDA approval. But this action brings the drug that much closer to marketability.


Bristol-Myers Squibb/Merck press release:
Bristol-Myers Squibb And Merck Joint Statement On FDA Advisory Committee Vote On Pargluva™ (Muraglitazar), An Investigational Oral Treatment For Type 2 Diabetes

New York Times story, Sept. 10:
Panel Backs Drug Amid Conflict Concerns

Public Citizen's press release:
Testimony Before FDA Advisory Committee on New Diabetes Drug Muraglitazar (Pargluva): Risks Outweigh the Benefits