But another molecule created when the body metabolizes Galvus does build up in the kidney.
The FDA could render a verdict on Merck's Januvia by mid-October and Novartis' Galvus by December.
Novartis created its first DPP4 drug candidate in 1996 and by 1998 had invented Galvus.
Novartis is only six weeks behind with its own similar diabetes pill, Galvus.
In studies of monkeys, Galvus and another DPP-4 inhibitor being developed by Bristol-Myers Squibb and AstraZeneca have caused skin lesions.
On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
Januvia and Galvus are the leaders of a new class of medicines called DPP-4 inhibitors, which block an enzyme (dipeptyl peptidase 4).
Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis.
Januvia was accepted by the U.S. Food and Drug Administration three months earlier than Galvus (an FDA decision on Januvia is expected by October).
It had been thought that Galvus might eke a marketing advantage over the fact that it is not processed by the kidneys, while Januvia is.
On a conference call, James Shannon, the drug giant's head of clinical research, said the FDA wants more data studying Galvus in patients with impaired kidneys.
On Monday, Novartis (nyse: NVS - news - people ) said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
Novartis' entry, Galvus, "has a fantastic side-effect profile, much better than other diabetes drugs at this point in development, " says Vasella, who thinks that the class could supplant older drugs.
Novartis could be facing a further delay on the U.S. approval of its diabetes drug Galvus, one of its most important experimental medicines, an analyst says, potentially giving an even bigger head start to rival Merck .
Other near-term issues Merck investors may want to focus on: being sure that Gardasil, an experimental cervical vaccine, outperforms a rival entrant from GlaxoSmithKline, and that Januvia, an experimental diabetes pill, beats competition from Novartis ' Galvus.
Januvia and Galvus appear not only to spare patients the side effects of older medicines, but also to help preserve the beta cells in the pancreas--the cells that produce insulin, and that often die off in diabetes patients.
Investors originally expected the Food and Drug Administration to approve Galvus by Nov. 30 of last year, but the FDA delayed its decision by three months in order to further scrutinize a series of skin reactions seen in primates who had received the drug.
In a note to investors released today, Prudential Equity Group's Timothy Anderson says that the FDA is likely to want even more information about this skin reaction, and that the agency might hold off on approving Galvus for as much as several more months.
Just over the past year, Merck (nyse: MRK - news - people ) has failed to get its pain drug Arcoxia approved, Sanofi-Aventis ran into a brick wall with the Food and Drug Administration over its obesity treatment rimonabant and Novartis (nyse: NVS - news - people ) has faced prolonged delays on its diabetes pill Galvus.
应用推荐