Differences more than skin deep

Unexplained skin lesions seen in primates receiving Galvus vildagliptin, a selective DPP-4 inhibitor for Type II diabetes, are probably what caused FDA to issue an approvable letter last week that requested a new study in patients with renal impairment. Merck & Co. Inc. ran such a study for its selective DPP-4 inhibitor, Januvia sitagliptin, which was approved in October. But Novartis AG elected not to run a trial as part of its NDA package because Galvus isn't excreted through the kidneys the way Januvia is.

Novartis (NVS; SWX:NOVN, Basel, Switzerland) is unsure how long the new trial will take since it has not yet met with FDA to determine exactly what is needed. The company hopes to meet with the agency in the next couple of weeks, but is not likely to give another update until its 1Q07 results are reported in April, according to company spokesperson Richard Booton...