Pulmonary-AllergyDrugsAdvisoryCommitteeMeeting分析.pptVIP

Pulmonary - Allergy Drugs Advisory Committee Meeting January 17, 2002 FLOVENT? DISKUS? NDA 20-833 ADVAIR DISKUS? NDA 21-077 FLOVENT? DISKUS? and ADVAIR DISKUS? David Wheadon, MD Senior Vice President, Regulatory Affairs GlaxoSmithKline sNDAs forFLOVENT DISKUS and ADVAIR DISKUS INDICATION Long term, twice-daily maintenance treatment of Chronic Obstructive Pulmonary Disease (including emphysema and chronic bronchitis) SEREVENT?(salmeterol xinafoate) Serevent Inhalation Aerosol approved for COPD, 1998 Approval sought for Serevent Diskus for the maintenance treatment of bronchospasm associated with COPD FLOVENT(fluticasone propionate) Currently Approved in US for maintenance treatment of asthma Approved for COPD in 67 countries outside US Worldwide exposure estimate - 14.4 million patient years Approval sought for Flovent Diskus for maintenance treatment of COPD at doses of 250mcg and 500mcg BID ADVAIR DISKUS(fluticasone propionate andsalmeterol inhalation powder) Currently approved for maintenance treatment of asthma Worldwide exposure estimate - 1.4 million patient years Approval sought for maintenance treatment of COPD at doses of 250/50mcg and 500/50mcg BID Impact of COPD in the US Affects an estimated 21.7 million Americans1 6.5 Million Diagnosed 4.3 Million Treated With Prescription Medications The fourth leading cause of death2 114,000 deaths in 19982 Third leading cause of death by 20203 Annual cost $30 billion2 $14.7 billion in direct healthcare costs $15.7 billion in indirect healthcare costs Global Initiative for ChronicObstructiveLungDisease Clinical Effects of ICS in COPD Reference N Duration Treatment/Day Outcome Nishimura et al., 1999 30 4 w BDP 3000mcg ? FEV1, ? Sx O’Brien et al., 2001 24 6 w BDP 1500mcg FEV1 preserved Thompson et al., 1992 30 6 w BDP 1000mcg ? FEV1, ? bronchitis Weiner et al., 1995 30 6 w BUD 800mcg ? FEV1, ? prn med Weiner et al., 1999 168 6 w BUD 1600mcg ? FEV1, ? prn med Auffarth et al., 1991 21 8 w BUD 1600mcg ? dy