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Allergan, Inc. NDA 21-701 tazarotene 1.5 and 4.5 mg capsules

Allergan, Inc. NDA 21-701 tazarotene 1.5 and 4.5 mg capsules. Backup slides presented FDA Advisory Committee July 12, 2004. Prior and Concomitant Therapy. Patients were not to have used:

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Allergan, Inc. NDA 21-701 tazarotene 1.5 and 4.5 mg capsules

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  1. Allergan, Inc.NDA 21-701tazarotene 1.5 and 4.5 mg capsules Backup slides presented FDA Advisory CommitteeJuly 12, 2004 Allergan, Inc. - Backup Files Presented

  2. Prior and Concomitant Therapy • Patients were not to have used: • Systemic medications (other than corticosteroids) known to affect bone (eg, alendronate sodium) in the 12 months before study entry • Systemic retinoids (eg, isotretinoin, acitretin, bexarotene) or oral or injectable systemic corticosteroids in the 8 weeks before study entry • PUVA, methotrexate, or cyclosporine in the 4 weeks before study entry • UVB treatment or topical therapies (eg, topical corticosteroids, topical retinoids, topical calcipotriene) that may have altered the course of psoriasis in the 2 weeks before study entry • Daily vitamin A supplements > 5,000 IU, vitamin D supplements > 400 IU, or calcium supplements > 1,300 mg in the 7 days before study entry C-028 Allergan, Inc. - Backup Files Presented

  3. Prior and Concomitant Therapy(cont.) • During their participation in the study, other than the use of study medication, patients were not to use any medications that could alter the course of their psoriasis or could interfere with the evaluation of the study medication • Therapies considered necessary for the patient’s welfare could be given at the discretion of the investigator • If the decision was made to administer a medication that may have affected the outcome of the study, the medication was to be administered in constant doses throughout the study C-029 Allergan, Inc. - Backup Files Presented

  4. Liver Function TestsNot Elevated Compared With Placebo *Placebo higher than tazarotene in 12 weeks tx study ^ Higher than placebo and higher with long term tx S-035 Allergan, Inc. - Backup Files Presented

  5. Patients Treated with Oral Tazarotene Had Greater Satisfaction with Their Study Medication(Study048P/049P) Oral Tazarotene 4.5 mg 79.5%were satisfied with their study medication Placebo 52.3%were satisfied with their study medication Patient Satisfaction with Treatment at Week 12 Mean satisfaction scores indicate statistically significant greater satisfaction with oral tazarotene than with placebo (p<0.001). E-134 Allergan, Inc. - Backup Files Presented

  6. Improvement in PQOL-12 is Correlated to Improvement in OLA (048P/049P)and Greater Than Placebo OLA Improvement at Week 12Relative to PQOL-12 Change Scores 1 grade OLA Improvement 2 grade OLA Improvement OLA ofmin or none Placebo MID=1.24 [-1.05, -0.62] Mean PQOL-12 Change Score [-2.08, -1.65]* [-2.79, -2.07]* [-3.42, -2.50]* * 95% confidence interval of the mean E-141 Allergan, Inc. - Backup Files Presented

  7. Bone Mineral Density Issue Femoral Neck BMD Data, 95% Tolerance Region, and +/-5% Straight-Line Tolerance Region • 94% of points in TR • 83% in “slice” (vs. 81% expected) • 11% below “slice” (vs. 13% exp.) • 6% above “slice” (vs. 5% exp.) • Mean shift: -0.01 (0.943 vs 0.933) • Median shift: -0.003 S-212 Allergan, Inc. - Backup Files Presented

  8. Bone Fractures Reported in 9 Patients in 048P, 049P, 052P, and 050P Trials S-086 Allergan, Inc. - Backup Files Presented

  9. No Apparent Association Between Fractures and BMD LS = lumbar spine, H = total hip, FN = femoral neck S-087 Allergan, Inc. - Backup Files Presented

  10. Patient 1115 (Apparent Loss of >50% Hip BMD Due to Scan of Unacceptable Quality) *Unacceptable quality scan S-183 Allergan, Inc. - Backup Files Presented

  11. Apparent Loss of ≥ 20% BMD from Baseline (Patient 3409) • 50-year old male with obesity (151 kg), diabetes, and sleep apnea • BMD assessment at limits of capability of BMD technology due to obesity • Patient started with high BMD/T score • Concomitant meds: aspirin, Glucovance, benazepril, amfebutamone, sertraline, pramipexole, saw palmetto S-206 Allergan, Inc. - Backup Files Presented

  12. Risk of Osteopenia and Osteoporosis In Patients with ≥ 5% Loss in BMD (050P) • Of 32 patients with ≥ 5% loss in BMD at any time: • 14 (44%) had normal BMD throughout the study • 12 (38%) had osteopenia at baseline and never became osteoporotic • 5 (16%) developed osteopenia (from normal at baseline) • None developed osteoporosis; 1 (3%) had osteoporosis at baseline and follow-up • No greater risk of osteoporosis in patients with ≥ 5% loss vs. patients who do not have ≥ 5% loss S-196 Allergan, Inc. - Backup Files Presented

  13. Minimal Effects on Thyroid Function S-188 Allergan, Inc. - Backup Files Presented

  14. Education Materials for Physicians • What Prescribers Need to Know Brochure • Prescriber Introduction Letter • Prescriber certification test • Medication Guide R-052 Allergan, Inc. - Backup Files Presented

  15. RiskMAP Roll-out • Broad target audience • Registration kits for physicians and pharmacies • Educational seminars • Professional meetings • Field force participation R-055 Allergan, Inc. - Backup Files Presented

  16. Age (Yrs) Body Weight, Gender, and Age Have No Effects on PK Study 048P Study 049P PC-017 Allergan, Inc. - Backup Files Presented

  17. Logistic Regression: Clinical Success* Versus Possible CovariatesStudies 048P/049P(N = 689) * Clinical success = None/Minimal OLA at Week 12 C-136 Allergan, Inc. - Backup Files Presented

  18. Incidence of Hyperglycemia S-189 Allergan, Inc. - Backup Files Presented

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