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FDA Panel Recommends Approval of Diabetes Drugs

Bruce Goldfarb

An advisory committee of the Food and Drug Administration (FDA) recommended the approval of two drugs—a long-awaited inhaled form of insulin for the treatment of type 1 and 2 diabetes (Exubera, Pfizer/Sanofi-Aventis) and muraglitazar (Pargluva, Merck/Bristol-Myers Squibb) for the treatment of type 2 diabetes.

The inhaled insulin is a powdered formulation developed by Pfizer in partnership with Sanofi-Aventis and San Carlos, Calif.–based Nektar Therapeutics. Using a proprietary delivery system, the patient administers the insulin through the mouth and nose prior to meals. Some patients may still need a longer-acting insulin in the mornings or evenings.

By a 7–2 vote, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted on September 8 that the inhaled insulin was safe and as effective as injectable insulin, but not superior.

Some panel members expressed concern about the lack of information on the long-term effects of inhaling powdered insulin. According to Pfizer, the company will launch a 12-year follow-up program to track potential problems with the drug.

Other companies reportedly exploring inhaled formulations of insulin are Eli Lilly and Co., in collaboration with Alkermes, and Novo Nordisk, in collaboration with Aradigm Corp.

DUAL-ACTION PPAR

On September 9, the advisory panel recommended approval of muraglitazar as a stand-alone treatment for type 2 diabetes or in combination with metformin.

The first of a new class of peroxisome proliferator–activated receptor (PPAR) drugs—the glitazars—muraglitazar may have cardiovascular effects greater than those of pioglitazone (Actos, Takeda/Eli Lilly) and rosiglitazone (Avandia, GlaxoSmithKline).

Glitazone drugs target PPAR-gamma, which is associated with insulin sensitivity and glycemic control. The glitazars target PPAR-gamma and PPAR-alpha, which is associated with regulation of lipids.

Sponsors presented clinical data showing that muraglitazar significantly reduced glycated hemoglobin (A1C), decreased triglycerides, and increased HDL cholesterol. The committee voted against recommending muraglitazar in combination with sulfonylureas because of potential side effects.

Another dual-action PPAR drug, tesaglitazar (Galida, AstraZeneca), is in late-stage clinical trials (DOC News, September 2005).

Although the FDA is not bound by the recommendations of its advisory panels, the agency typically follows their advice. Clearance for marketing the drugs is expected within 6 months.

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