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One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007

One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007. Amy M. Taylor, MD, MHS, FAAP Medical Officer Pediatric and Maternal Health Staff Office of New Drugs Food and Drug Administration. Background Drug Information.

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One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007

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  1. One Year Post-ExclusivityAdverse Event Review:FluvastatinPediatric Advisory Committee MeetingApril 11, 2007 Amy M. Taylor, MD, MHS, FAAP Medical Officer Pediatric and Maternal Health Staff Office of New Drugs Food and Drug Administration

  2. Background Drug Information • Drug: Lescol®, Lescol XL ®(fluvastatin sodium) • Therapeutic Category: Lipid lowering agent • Sponsor: Novartis • Indication (pediatric): As an adjunct to diet to reduce total cholesterol, LDL-C and Apo B levels in adolescent girls who are at least one-year post-menarche and boys age 10-16 years with heterozygous familial hypercholesterolemia. • Original Market Approval: Lescol ® (12/31/93), Lescol® XL (10/6/00) • Pediatric Exclusivity Granted: December 15, 2005

  3. Post Exclusivity Review • Pediatric use limited (< 1% of all prescriptions)1 • Exclusivity Studies: Two open label uncontrolled dose-titration studies in pediatric patients with heterozygous familial hypercholesterolemia • Exclusivity studies resulted in labeling with a pediatric indication, dosing information, adverse event information, and a description of the clinical study results. • In the one-year post-exclusivity period, no pediatric adverse events were reported. 1Verispan, LLC, Vector One® National (VONA) Data extracted 2-21-2007

  4. Pediatric Adverse Events Since Market Approval (n=7) • Leukopenia and Neutropenia – 1 • Chorioretinitis – 1 • In-utero exposure – 1 • Intentional overdose – 1 • Accidental overdose – 3 The review of adverse events since market approval did not identify any safety signals unique to the pediatric population.

  5. Summary: Fluvastatin • Exclusivity studies resulted in labeling with a pediatric indication, dosing information, adverse event information, and a description of the clinical study results. • Pediatric use limited (< 1% of all prescriptions)1 • In the one-year post-exclusivity period, no pediatric adverse events reported. No safety signals identified since market approval unique to the pediatric population. • This completes the one-year post-exclusivity AE reporting as mandated by BPCA. • FDA recommends routine monitoring of AEs for fluvastatin in all populations. • Does the Advisory Committee concur? 1Verispan, LLC, Vector One® National (VONA) Data extracted 2-21-2007

  6. OSE Jo Wyeth Rosemary Johann-Liang Vicky Borders-Hemphill Solomon Iyasu Lanh Green Nancy Clark Sammie Beam DEMP Eileen Craig Eric Colman PMHS Kristin Phucas Jean Temeck Lisa Mathis OPT Barbara Gould Dianne Murphy Acknowledgements

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