文档介绍：Pulmonary - Allergy Drugs mittee Meeting
ADVAIR DISKUS® NDA 21-077
ADVAIR DISKUS 500/50(fluticasone propionate and salmeterol inhalation powder)
C. Elaine Jones,
Vice President
Respiratory Regulatory Affairs
Impact of COPD in the US
Affects an estimated 20 million Americans
Annual cost $ billion
$ billion in direct healthcare arycosts
$ billion in indirect morbidity and mortality costs
The fourth leading cause of death
120,000 deaths every year
More people die every day from COPD than from breast cancer and bined
Expected to be third by 2020
Patient Burden of COPD
Poor physical functioning
Significant symptoms
Social isolation
Fear of exacerbations
Frequent hospitalizations
Increased mortality
COPD Is The Only Major Cause Of Death That Has Increased Significantly In Recent Years
Change in age-adjusted death rate
in USA, from 1970 to 2002 (%)
COPD
Diabetes
Cancer
Heart
Disease
Stroke
Adapted from Jemal et al. JAMA. 2005;294:1255-1259.
Unmet Medical Needs in COPD
Increasing morbidity and mortality

Limited treatment options
Improvement in FEV1 forms basis of approvals
Do not address the progressive nature of COPD
Advair Diskus
Advair Diskus 250/50 currently approved on basis of lung function improvement
Maintenance treatment of airflow obstruction in patients with COPD associated with Chronic Bronchitis
Advair Diskus 500/50 is the focus of