Pulmonary Allergy Drugs Advisory Committee Meeting.ppt

1、Pulmonary - Allergy Drugs Advisory Committee Meeting,ADVAIR DISKUS NDA 21-077,ADVAIR DISKUS 500/50(fluticasone propionate and salmeterol inhalation powder),C. Elaine Jones, Ph.D Vice President Respiratory Regulatory Affairs,Impact of COPD in the US,Affects an estimated 20 million Americans Annual co

2、st $37.2 billion $20.9 billion in direct healthcare arycosts $16.3 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 diabetes combined Expected to be third by 2020,Patient Burd

3、en 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,D

4、iabetes,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/

5、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 todays presentation,Advair Diskus 500/50Clinical Development Program,Large clinical development progr

6、am Over 8000 patients in pivotal trials Over 2100 patients in the U.S. Advair Diskus 500/50 addresses some of the unmet needs for patients with COPD Exacerbations Survival,Proposed Indication,“ADVAIR DISKUS 500/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patie

7、nts with chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema, and to increase survival and reduce exacerbations in patients with forced expiratory volume in 1 second (FEV1) 60% of predicted.”,Order of GSK Presentation,Efficacy and Safety Data from theAdvair Diskus 500/50 Clinical Program Katharine Knobil, MD Vice President Respiratory Clinical Development Cli