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FDA Conference Call: August 13, 2002
FDA Personnel;
Jeri El-Hage, Ph.D., Toxicology Team Leader
Jena Weber, Project Manager
TPNA Personnel:
David Baron, Ph.D., Director, Nonclinical Safety and Efficacy
Janet Haskins, Manager, Regulatory Affairs
Pat Frank, Ph.D., TPNA Consultant
This teleconference was held as a follow-up to a discussion between TPNA and the
Agency on July 31, 2002. The purpose of this this conference call was so that Dr. El-
Hage could expand upon the nonclinical data related to dual PPAR agonist that was
discussed shared-with TPNA onduring-the July 31, 2002.-conference call.
Dr. El-Hage informed TPNA that nonclinical data observed in several standard 2-year rat
and mouse bioassay studies with several other dual PPAR agonists, similar-to
pioglitazone, were shown to cause transitional cell tumors in the bladder and kidneys of
male and female rats and male mice Therefore, the Division is considering the relevance
of these findings to becoming concerned with-the potentially long term tumorigenic
effects of-thisese class of drugs. in humans. She also noted that in follow-up unspecified
mechanistic studies, no evidence of irritation by crystalluria or calculi was noted.
Dr. El-Hage then described a tumor promoter-model study that was conducted by another
sponsorcompany in which pioglitazone was administered. The study was designed as
follows:
BBN was given to male Fisher rats in their drinking water for four weeks.
Four groups were designated:
Pioglitazone 40 mg/kg/day after BBN
Confidential - Subject to Protective Order
TAK-BAROND-00301714
Produced in MDL on 09/08/12
Source: https://www.indup6319-oooonts.ucsf.edu/docs/rtjf0226

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