文档介绍：Arthritis mittee March 5, 2003
Lee S. Simon, MD
Division Director
Analgesic, Anti-inflammatory, Ophthalmologic Drug Products
HFD-550/CDER/FDA
Agenda
Regulatory history of Arava in the context of therapy for Rheumatoid arthritis
A discussion of e measures for disability and physical function
Sponsor presentation of efficacy
FDA statisticians’ assessment of impact of placebo withdrawals on 2 year landmark analyses
Representing data for discussion regarding change in guidance
Discussion of questions regarding efficacy of Arava in the context of the indication for improvement in physical function
Discussion of the RA guidance document of 1999 and the indication for improvement in disability which presently requires 2-5 years of data
Agenda continued
FDA presentation regarding hepatotoxicity associated with Arava
Sponsor presentation of overall safety of Arava and its benefit/risk ratio for use in the context of the universe of therapies for RA
A presentation regarding munication
Discussion regarding questions
Arava: Regulatory History in the Context of Treatments for RA
Lee S. Simon, MD
Division Director
Analgesic, Anti-inflammatory, Ophthalmologic Drug Products
HFD-550/CDER/FDA
Impact of Arthritis in the .
In 1994: - 40 million Americans were affected by arthritis
By 2020: 59 million (1 in 6 persons) will be affected – a 57% increase from 1983, when 35 million persons had arthritis
Arthritis costs the . economy more than $54 billion/yr in lost wages and medical care
Impact of Arthritis in the .
Leading cause of disability in people over age 65
Limits activities of daily living (ADL) of 7 million people
6 million Americans report having arthritis but never seeing a doctor for help
Rheumatoid Arthritis
Affects about 1% of the US population between the ages of 20-50
Heterogeneous disease
Variable course
Systemic inflammatory disease associated with an as yet poorly understood immune dysfunction
Leads to the development of destructive erosive disease