Food and Drug Administration
Center for Drug Evaluation
and Research
Pulmonary-Allergy Drugs Advisory
Committee
Holiday Inn,
QUESTIONS
NDA 21-573, Ariflo (cilomilast) Tablets 15mg, by GlaxoSmithKline,
for use in Chronic Obstructive Pulmonary Disease
1.
Has cilomilast at a dose of 15
mg twice daily shown a magnitude and consistency of efficacy that is sufficient
to support approval of cilomilast for the maintenance of lung function (FEV1)
in patients with COPD?
a)
If not, what further efficacy
data should be obtained?
2.
Is the safety database (aside
from the concern for vasculitis) for cilomilast for the maintenance of lung
function (FEV 1) in patients with COPD sufficient to support approval?
a)
If not, what further safety data
should be obtained?
3.
Do you feel that the concern of
mesenteric vasculitis has been adequately studied to be dismissed as a safety
concern in humans?
a)
If not, what further data should
be obtained?
4.
Do the efficacy and safety data
provide substantial and convincing evidence that support the approval of
cilomilast at a dose of 15 mg twice daily for the maintenance of lung function
(FEV1) in patients with COPD?