FDA PANEL PUSHES FOR APPROVAL OF PARGLUVA
An FDA advisory panel has recommended approving the experimental diabetes drug Pargluva, which was co-developed by Bristol-Myers Squibb (BMS) and Merck, despite concerns over the product's cardiovascular risks.
In a recent 8-1 vote, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee said the FDA should approve the Type 2 diabetes treatment as a stand-alone therapy. The panel also voted 7-2 in favor of approving the drug in combination with metformin, which is marketed by BMS as Glucophage, and is available in generic form.
The panel, however, voted 7-2 to reject approving Pargluva (muraglitazar) as a combination treatment with the diabetes drug sulfonylurea.
If approved, Pargluva would become the first marketed agent in a new class of compounds called glitazars, BMS and Merck said. Some analysts have said the drug could achieve annual sales of more than $1 billion. But others say its market penetration could be limited. If Pargluva is not approved in combination therapy with sulfonylurea, "it will exclude a large portion of the diabetes market," said Al Rauch, an analyst with A.G. Edwards & Sons.
Pargluva is a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) activator. Activation of PPAR-gamma is associated with reductions in plasma glucose levels, while activation of PPAR-alpha is associated with reductions in plasma triglyceride levels and increases in high-density lipoprotein, or "good" cholesterol (HDL-C) levels, according to the firms.
While Pargluva and other dual-PPAR agonists have proven effective in clinical studies, many trial subjects experienced elevated fluid retention while taking the drugs, a condition that could lead to edema or potentially aggravate pre-existing heart conditions, FDA reviewers said.