Novartis extends Galvus resubmission target to mid-‘09
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
An FDA-requested safety study of Novartis' antidiabetic Galvus (vildagliptin) will take at least six months, not "weeks" as the firm originally suggested, and will enroll "several hundred" patients with renal impairment, Head of Pharma Development James Shannon tells a July 17 earnings call. The study, requested in FDA's Feb. 23 "approvable" letter for the dipeptidyl peptidase-4 agent, responds to concerns about skin lesions seen in primates and healthy volunteers at four to six times the proposed therapeutic dose, Shannon said. FDA is concerned that susceptible populations may get to those levels, he explained. FDA has requested that all manufacturers developing DPP-4 agents characterize their compounds' dermatologic safety profiles (1Pharmaceutical Approvals Monthly March 2007, p. 20). Novartis submitted a study protocol in June and, if FDA agrees, anticipates starting the renal impairment study in the fourth quarter of 2007. "We would resubmit the dossier to the FDA sometime in mid-2009," Shannon predicted…