1 One Year Post-Exclusivity Adverse Event Review: Ertapenem Pediatric Advisory Committee Meeting November 16, 2006 Alan M. Shapiro, MD, PhD, FAAP Medical.

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1 One Year Post-Exclusivity Adverse Event Review: Ertapenem Pediatric Advisory Committee Meeting November 16, 2006 Alan M. Shapiro, MD, PhD, FAAP Medical Officer Pediatrics and Maternal Health Staff Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration

2 Background Drug Information Drug: Invanz ® (ertapenem) Therapeutic Category: Anti-infective -carbapenem Sponsor: Merck and Company, Inc. Indication: Treatment of complicated intra-abdominal infections, complicated skin and skin structure infections, community acquired pneumonia, complicated urinary tract infections, and acute pelvic infections Original Market Approval: November 21, 2001 Pediatric Exclusivity Granted: February 11, 2005

3 Ertapenem Pediatric Exclusivity Trials Single dose pharmacokinetic (PK) study in patients requiring antibiotic therapy Single dose PK study of cerebral spinal fluid (CSF) concentrations of ertapenem in patients with meningitis Double blind multi-center comparative safety and efficacy study of ertapenem versus ceftriaxone for community-acquired pneumonia, complicated UTI, skin and soft tissue infections Double blind prospective multi-center comparative study of ertapenem versus ticarcillin/clavulanate for the treatment of complicated intra-abdominal infections and acute pelvic infections

4 Exclusivity Trials Results From the PK study, the appropriate dose of ertapenem was determined: 15mg/kg IV every 12 hours for patients 3 months to 12 years and 1 gram once daily for patients 13 to 17 years of age CSF concentrations obtained were not adequate for the treatment of bacterial meningitis The safety profile of ertapenem in pediatric studies was similar to the comparators and similar to the profile described in adults. Most frequent drug- related side effects were diarrhea and infusion site pain.

5 Exclusivity Trials Results (cont.) In the two comparative studies, the response rates of ertapenem versus the combined comparators were similar  Safety and effectiveness of INVANZ in pediatric patients 3 months to 17 years of age are supported by: –evidence from adequate and well-controlled studies in adults –pharmacokinetic data in pediatric patients –additional data from comparator-controlled studies in pediatric patients 3 months to 17 years of age

6 Adverse Events No pediatric AEs were reported to AERS during the year following exclusivity 2 pediatric AEs (1 serious) since market approval: –Serious: 16 year old male originally treated with ceftriaxone and clindamycin for periorbital cellulitis – Reaction to ceftriaxone and was initially switched to metronidazole, vancomycin and levofloxacin. Subsequently placed on ertapenem –Developed neurological changes including agitation and combative behavior and diagnosed with a frontal brain abscess by CT scan. Improved following craniotomy and drainage of the abscess –Ertapenem is not recommended for treatment of meningitis in pediatric population due to lack of sufficient CSF penetration

7 Drug Use The pediatric use of ertapenem is relatively small, a total of 158 associated discharges August 2004 – July (~ 1% of total ertapenem discharges) The pediatric use of ertapenem increased from 70 to 88 associated discharges from the six month period prior to receiving exclusivity as compared to the following six months 1 1 Premier Informatics Data Extracted

8 Summary This summary of ertapenem AE reports is presented in abbreviated format because: –There are no concerning unlabeled safety signals –Pediatric use is limited with few AE reports This completes the one-year post-exclusivity adverse event monitoring as mandated by BPCA The FDA recommends routine monitoring of ertapenem for AEs in all populations Does the Advisory Committee concur?

9 Acknowledgements OSE Ronald Wassel Rosemary Johann-Liang Mark Avigan David Moeny Toni Piazza-Hepp OND Linda Forsyth Peter Kim Thomas Smith Jean Mulinde