AstraZeneca and Bristol Myers Squibb have reiterated plans to seek FDA approval of their new type 2 diabetes drug, Saxagliptin, early next year, even though a similar Novartis drug has been delayed because of safety concerns.
Saxagliptin, Galvus and Merck & Co.’s Januvia belong to a new class of drugs, so- called DPP-4 inhibitors, which increase and prolong the action of natural hormones in the body
called incretins.
These decrease blood sugar by increasing consumption of sugar
by the body, mainly through increasing insulin production in the pancreas, and
by reducing production of sugar by the liver.
While Januvia was approved in late 2006 and is already on the market, Novartis said last week that the Food and Drug Administration wants more data on Galvus, and observers believe the pill may be delayed for more than a year.
The FDA delay is believed a result of agency concern that a biproduct of Galvus may build up in patients with kidney problems and lead to skin lesions, which were seen in tests with laboratory animals. Saxagliptin also is associated with these skin lesions.
Nevertheless, AstraZeneca Chief Executive Officer David Brennan told Bloomberg News that the U.K. drugmaker hasn't "seen anything that would suggest to us that we have a particular issue.
"It seems for this class of products, each one has a slightly different profile so the discussions that we had last [with the FDA] suggest to us that we’re on the right track," Brennan said.
Initial results from late-stage trials of saxagliptin will be released at the American Diabetes Association meeting in June, Brennan added.