Bristol-Myers Squibb and Merck & Co on Friday received a partial thumbs up from a US Food and Drug Administration advisory panel for its new diabetes drug, Pargluva (muraglitazar). The panel, despite a very positive pre-meeting briefing paper issued last week [[09/09/05c]], decided to give Pargluva the green light as a monotherapy and in combination with the generic drug metformin. However, they recommended against its use alongside sulfonylurea drugs, possibly impacting on the drug’s potential marketability versus its closest rivals – GlaxoSmithKline’s Avandia (rosiglitazone) and Eli Lilly/Takeda’s Actos (pioglitazone).
Pargluva belongs to the peroxisome proliferator-activator agonist class of drugs, and is designed have a dual mechanism of action by tackling both insulin resistance and high blood lipids in type 2 diabetes. Concerns around a possible link to oedema and heart failure were widely investigated during clinical studies, and B-MS and Merck said in a statement that they have a pharmacovigilance plan in place that will allow the companies to “continually assess” the risk:benefit profile of Pargluva going forward.
A decision on Pargluva’s approvability should be made by the end of the year. With a sales potential in the region of $3 billion dollars, both B-MS and Merck will be keeping their fingers crossed that their fortunes are improved.