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CLINICAL EFFICACY Oral Telithromycin

CLINICAL EFFICACY Oral Telithromycin. George Rochester, PhD, CCRN Statistical Reviewer Division of Biometrics III Division of Anti-infective Drug Products rochesterg@cder.fda.gov. Outline. Phase III clinical database Censored data Clinical or bacteriologic efficacy by indication

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CLINICAL EFFICACY Oral Telithromycin

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  1. CLINICAL EFFICACYOral Telithromycin George Rochester, PhD, CCRN Statistical Reviewer Division of Biometrics III Division of Anti-infective Drug Products rochesterg@cder.fda.gov

  2. Outline • Phase III clinical database • Censored data • Clinical or bacteriologic efficacy by indication • Overall conclusion

  3. Phase III Clinical Database by Type of Study and Indication

  4. Censored Data • Four investigators were censored by the FDA. • Total number of patients excluded were 186. • Patients were excluded from all indications except T/P. • Both FDA’s and Sponsor’s analyses excluded all subjects from the censored sites.

  5. Phase III Clinical Data • Dosing of interest was for 5 days for AECB, AMS and T/P, and 7-10 days for CAP. • All studies had a designated test-of-cure (TOC) window for assessing the clinical or bacteriologic response. • TOC varied by indication but was always specified in the study protocol.

  6. Definition of Populations • The primary efficacy populations for CAP, AECB and AMS are mITTandPPc. • mITT: All randomized subjects who met disease definition and received at least one dose of study drug. • PPc: mITT subjects minus those with major protocol violations.

  7. Community Acquired Pneumonia

  8. CAP: Clinical Response -TOC

  9. Acute Exacerbation OfChronic Bronchitis

  10. AECB Definitions • Inclusion: Documented history of chronic bronchitis, FEV1/FVC < 70% (tests made in the previous 12 months) • Presentation: cough,  sputum volume,  sputum purulence, and/or dyspnea • Cure:resolution of all symptoms and no subsequent antimicrobial therapy at TOC

  11. AECB: Clinical Response -TOC

  12. ACUTE MAXILLARY SINUSITIS

  13. Sinusitis: Clinical Response -TOC

  14. GROUP A -HEMOLYTIC STREPTOCOCCALTONSILLITIS/PHARYNGITIS

  15. T/P: Regulatory Considerations • Penicillin is the gold standard comparator • Primary efficacy is based on microbiologic eradication • Any product with an absolute eradication rate of < 85% in the PP population should not be considered first line therapy

  16. T/P: Conclusion • T/P is a mild disease • Targeted population is typically children • Many alternative therapies • Insufficient evidence of activity against erythromycin resistant S. pyogenes • Risk/Benefit must be considered

  17. Overall Conclusion • FDA’s efficacy analyses are consistent with those of the applicant. • Adequate, well-controlled trials must demonstrate safety and efficacy.

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