Meeting Questions

1
Meeting Questions

• Arthritis Advisory Committee
• November 29, 2006

2
Discussion Points

• Discuss the need for new therapies in children
  with juvenile rheumatoid arthritis (JRA),
  including therapies such as celecoxib.
• Discuss the safety of celecoxib when used in
  children with JRA based on the data derived from
  the pediatric studies, the known risks, including
  cardiovascular risks, in adults and the risks of
  alternative therapies.

3
Question 1.

• Do the available data demonstrate that Celebrex
  is effective in the treatment of JRA?
• If not, what additional studies would you
  recommend to further assess efficacy?

4
Question 2.

• Do the available data demonstrate that Celebrex
  is safe in the treatment of JRA?
• If not, what additional studies should be
  undertaken to further assess safety?
• If yes, do you recommend any phase 4 studies to
  further characterize the safety of Celebrex in
  JRA?

5
Question 3.

• Is the risk/benefit ratio of celecoxib in the
  treatment of JRA adequate to support the approval
  of the product for this indication?

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