Bristol-Myers Squibb has said may have to abandon efforts to develop its new diabetes drug Pargluva (muraglitazar), following the US Food and Drug Administration (FDA)’s request for more data on side effects [[19/10/05g]].
In a statement, the company said that generating the additional information requested by the agency would require clinical trials that could take up to five years to complete, placing the future of the whole programme in doubt. B-MS is developing Pargluva alongside Merck & Co, and both companies, facing patent expiries on key products, have been counting on the diabetes drug to contribute to future sales growth. Earlier forecasts of the product’s sales potential had been as high as $3 billion dollars.
The FDA’s concerns are thought to relate to possible cardiovascular side effects, including heart failure, which were linked to Pargluva earlier this year [[09/09/05c]]. In September, an FDA advisory committee gave is backing to the drug, saying that it should be approved as a monotherapy and in combination with the diabetes treatment metformin, but not sulfonylureas, in type 2 diabetics [[12/09/05b]].
B-MS said it would give further information on Pargluva’s prospects after additional discussions with the agency. It also said it would be talking to Merck about its continued involvement in the product.
Pargluva is a dual peroxisome proliferator-activated receptor (PPAR) agonist, affecting both the alpha and gamma receptors unlike earlier glitazone drugs - such as GlaxoSmithKline’s Avandia (rosiglitazone) and Takeda/Eli Lilly’s Actos (pioglitazone) – that only affect the alpha receptor. The lead product in a new class known as glitazars, it is designed also have a dual mechanism of action, tackling both insulin resistance and high blood lipids in patients with type 2 diabetes [[14/06/05d]].