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One Year Post-Exclusivity
Adverse Event Review:
Imiquimod
Pediatric Advisory Committee Meeting
November 18, 2008
Amy M. Taylor, MD, MHS, FAAP
Medical Officer
Pediatric and Maternal Health Staff
Office of New Drugs

Food and Drug Administration
Background Drug Information
Drug: AldaraTM (Imiquimod) Topical Cream
Therapeutic Category: immune response modifier
Sponsor: Graceway Pharmaceuticals, LLC
Original Market Approval: February 27, 1997
Pediatric Exclusivity Granted: December 13, 2006
Background Drug Information
Indications:
– Treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or
scalp in immunocompetent adults
– Treatment of biopsy confirmed primary superficial basal cell carcinoma in immunocompetent adults;
– Treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or
older

– Limitations of Use: Studies in children ages 2 to 12 years with molluscum contagiosum (MC) failed to demonstrate efficacy Background Drug Information
Dosage:
– Actinic keratosis: 2 times per week x 16 weeks– Superficial basal cell carcinoma: 5 times per – External genital warts: 3 times per week until Background Drug Use Information
• Aldara™ prescriptions in the pediatric population (ages 0-16 years) accounted for approximately 21% of total dispensed Aldara™ prescriptions* • Of the prescriptions dispensed to pediatric patients, 40% were dispensed to patients aged 6-10 years and 38% dispensed to patients aged 11-16 years • Top diagnoses** – viral warts and MC *Source: SDI Vector One® National, Years 2005 – 2007. Data Extracted 6-2008.
**Source: SDI Physician Drug and Diagnosis Audit, Years 2005 – 2007. Data Extracted 6-2008 Exclusivity Studies
Pharmacokinetic study result:• Absorption of imiquimod following topical application in pediatric patients was comparable to adults Exclusivity Studies
Efficacy• Two double-blind, vehicle-controlled safety and efficacy studies in 702 pediatric patients age 2 to 12 years with MC – 470 patients exposed to Aldara™– Treatment was up to 16 weeks Exclusivity Studies
Efficacy results:• Since the vehicle clearance rates were higher than Aldara™, these studies failed to demonstrate • No indication for molluscum contagiosum granted – Study 1 –Aldara™ (24%); vehicle (26%) – Study 2 – Aldara™ (24%); vehicle (28%) Exclusivity Studies
Safety results:• In general, adverse events in the Aldara™ group resembled those seen in studies with adults • The most frequently reported possibly or probably related adverse event was application site reaction (31% in Aldara™ group and 20% in vehicle group) • A decrease in WBC and absolute neutrophil Exclusivity Studies
Safety results (continued):• Severe local reactions reported in Aldara™ group – Erythema (28%)– Edema– Scabbing/crusting– Flaking/scaling– Erosion – Weeping/exudate Labeling Sections ChangedHighlights Section Section 1 Indications and Usage
1.4 Limitations of Use: Studies in children 2
to 12 years with MC failed to demonstrate efficacy Details of Specific Labeling Changes continued
Section 8 Use in Specific Populations
8.4 Pediatric Use
– A description of the two efficacy studies and – Adverse events observed during the clinical studies, including incidence of severe local – A description of the pharmacokinetic study and results including extent of systemic absorption and decrease in median WBC/Absolute Neutrophil Pediatric Adverse Events in 1
Year Post Exclusivity Period
Crude Counts1 of AERS Reports for All Sources from Date Pediatric Exclusivity Was Granted (12/13/2006 to 1/13/2008) 1May include duplicates2Serious adverse drug experience per regulatory definition (CFR 314.80), which includes death, life threatening, hospitalization, disability, and congenital anomaly Pediatric Adverse Events Since
Marketing Approval
Crude Counts1 of AERS Reports for All Sources from Marketing Approval Date to January 13, 2008 (US counts in parentheses) 1May include duplicates2Serious adverse drug experience per regulatory definition (CFR 314.80), which includes death, life threatening, hospitalization, disability, and congenital anomaly Pediatric Uses Reported with Adverse
Events Since Marketing Approval
Viral Warts (49%)Molluscum Contagiosum (24%)Warts and Common Warts (7%)Genital Warts (6%)Plantar Warts (3%)Alopecia (3%)Venereal Warts (1%)Herpes (1%)Actinic Keratosis (1%)Not Reported (5%) Pediatric Adverse Events Since
Marketing Approval
Crude Counts1 of AERS Reports for All Sources from Marketing Approval Date to January 13, 2008 (US counts in parentheses) 1May include duplicates2Serious adverse drug experience per regulatory definition (CFR 314.80), which includes death, life threatening, hospitalization, disability, and congenital anomaly Pediatric Deaths Since Market Approval
gunshot while on 3rd month of second course of imiquimod (12.5 mg) three times weekly for viral warts. Total treatment duration 31 weeks. No known history of depression. This is a labeled event.
Pediatric Adverse Events Since
Marketing Approval
Crude Counts1 of AERS Reports for All Sources from Marketing Approval Date to January 13, 2008 (US counts in parentheses) 1May include duplicates2Serious adverse drug experience per regulatory definition (CFR 314.80), which includes death, life threatening, hospitalization, disability, and congenital anomaly Serious Pediatric Adverse Events Since
Market Approval (N=12)
Neurologic (n=3) • Seizures (n=2); labeled• Temporary paralysis (n=1); labeledCongenital Anomaly (n=2)• Undecended testicles, GU reflux, ASD, VSD; • Hirschsprung’s disease; unlabeledHematologic (n=1)• Thrombocytopenia purpura; labeled Serious Pediatric Adverse Events Since
Market Approval
Localized reactions (n=6) labeled• 7 year old female with a history of cerebral palsy after two applications for genital warts developed extreme swelling and inability to void necessitating catheterization in the emergency room. Patient also diagnosed with viral infection after developing a sore throat and low grade fever.
• 15 year old female with burning blisters, swelling and inability to void after one application for genital warts. Treated with topical lidocaine.
• 4 year old female with burning pain and inability to void, fever, and flu-like symptoms after 3 days of treatment (daily application) for herpes. Patient was hospitalized 2 days later.
Serious Pediatric Adverse Events Since
Market Approval
Localized reactions (n=6) labeled• 15 year old female with skin burns, blisters, pain upon urination, fever and fatigue after 5 days of treatment (1/2 packet 3 times/week) for genital warts. Patient was hospitalized and treated with antibiotics for the skin burns and blisters • 16 year old female with burning, erosions, and ulcerations after 3 days of treatment (1 packet daily) for genital warts. Patient was hospitalized after developing fever, increase WBC (14,000), and flu-like symptoms.
• 10 year old male with an application site abscess requiring incision and drainage and antibiotics after 1 month of treatment (unknown dosage every other day for 2 weeks and daily for 2 weeks) for MC. 17.6 Patients Being Treated for External Genital Warts – Female patients should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can result in pain or swelling and may cause difficulty in passing urine.
Summary: Imiquimod
• Pediatrics accounts for 21% of Aldara ™ use*• Despite studies showing lack of efficacy, off- label use is common including treatment of MC • Pediatric female patients have reported inability to void secondary to severe local reactions during – The Review Division is planning to update this *Source: SDI Vector One® National, Years 2005 – 2007. Data Extracted 6-2008.
Question for the Committee
• In addition to planning to update the labeling related to severe local reactions in females with use in the genital area, FDA will continue its standard, ongoing safety Acknowledgements
• Judith Cope, M.D., M.P.H.
• Dianne Murphy, M.D.

Source: http://www.aldara1.com/2008-4399s1-10%20(Imiquimod).pdf

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