Allergan inc nda 21 701 tazarotene 1 5 and 4 5 mg capsules
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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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Allergan inc nda 21 701 tazarotene 1 5 and 4 5 mg capsules

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


Prior and concomitant therapy

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


Prior and concomitant therapy cont

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


Liver function tests not elevated compared with placebo

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


Allergan inc nda 21 701 tazarotene 1 5 and 4 5 mg capsules

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


Allergan inc nda 21 701 tazarotene 1 5 and 4 5 mg capsules

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


Bone mineral density issue

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


Bone fractures reported in 9 patients in 048p 049p 052p and 050p trials

Bone Fractures Reported in 9 Patients in 048P, 049P, 052P, and 050P Trials

S-086

Allergan, Inc. - Backup Files Presented


No apparent association between fractures and bmd

No Apparent Association Between Fractures and BMD

LS = lumbar spine, H = total hip, FN = femoral neck

S-087

Allergan, Inc. - Backup Files Presented


Patient 1115 apparent loss of 50 hip bmd due to scan of unacceptable quality

Patient 1115 (Apparent Loss of >50% Hip BMD Due to Scan of Unacceptable Quality)

*Unacceptable quality scan

S-183

Allergan, Inc. - Backup Files Presented


Apparent loss of 20 bmd from baseline patient 3409

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


Risk of osteopenia and osteoporosis in patients with 5 loss in bmd 050p

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


Minimal effects on thyroid function

Minimal Effects on Thyroid Function

S-188

Allergan, Inc. - Backup Files Presented


Education materials for physicians

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


Riskmap roll out

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


Body weight gender and age have no effects on pk

Age (Yrs)

Body Weight, Gender, and Age Have No Effects on PK

Study 048P

Study 049P

PC-017

Allergan, Inc. - Backup Files Presented


Logistic regression clinical success versus possible covariates studies 048p 049p n 689

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


Incidence of hyperglycemia

Incidence of Hyperglycemia

S-189

Allergan, Inc. - Backup Files Presented


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