FDA Advisory Committee Questions:

Telithromycin

4/26/01

  1. Given the risks of cardiac and hepatic toxicity of telithromycin, does the efficacy for telithromycin in respiratory infections supports its use for:

community acquired pneumonia;

acute exacerbation of chronic bronchitis;

acute sinusitis?

In your discussion please comment on the following:

  1. Has the applicant provided sufficient data to warrant a claim for the treatment of community-acquired pneumonia due to penicillin-resistant S. pneumoniae (PRSP)?

If NO, what additional studies should be conducted?

  1. Is there sufficient evidence that an infection due to erythromycin-resistant S. pneumoniae (ERSP) has a negative impact on clinical outcome compared to that of sensitive strains of S. pneumoniae?
  2. If YES, has the applicant provided sufficient data to warrant a claim for the treatment of community acquired pneumonia due to erythromycin-resistant S. pneumoniae (ERSP)?

    Comment on the potential for concurrent-resistance of telithromycin and the macrolide antimicrobials?

  3. If the committee recommends approval, should this approval involve restrictions? For example, restrictions in the label use in special populations only, limitations in access or distribution.

II. If the committee has not recommended approval, please provide recommendations for additional studies if appropriate.