FOOD
AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS
ADVISORY COMMITTEE (AIDAC) MEETING
NDA
21-158, Factive® (gemifloxacin) Tablets, Parexel
International, U.S. Agent for LG LifeSciences, Ltd., proposed for the treatment
of community acquired pneumonia and acute bacterial exacerbation of chronic
bronchitis
1.
Based on the data presented and in
your scientific and clinical opinion, do the benefits of gemifloxacin therapy
outweigh the risks for the proposed indications of:
(a) Community
acquired pneumonia
(b) Acute
bacterial exacerbation of chronic bronchitis
Please include as
part of your discussion:
Ÿ
The clinical and microbiologic
benefits of gemifloxacin
Ÿ
The significance of the rash,
particularly as it relates to the likelihood of more severe dermatological
manifestations with broader use and the likelihood of cross-sensitization to
other fluoroquinolones.
Ÿ
The hepatic toxicity profile of the
drug
2.
If the answer to question (1a/1b) is
yes, please discuss the types of information that should be provided to
physicians and patients. Please focus on
the elements outlined in question 1 as well as any other issues you believe
relevant. Please include as part of this
discussion any caveats as to how and to whom the drug should be
administered. For any risk communication/management
strategy that may be appropriate, please comment on how practical and/or
effective such strategies may be.
3.
If the answer to (1a/1b) is no,
please recommend what additional studies or information should be obtained for
(a) Community
acquired pneumonia
(b) Acute
bacterial exacerbation of chronic bronchitis