LOTRONEX FDA Gastrointestinal Drugs Advisory Committee

1
LOTRONEXFDA Gastrointestinal Drugs Advisory
Committee

• Richard Kent, MD
• Chief Medical Officer
• Glaxo Wellcome

2
LOTRONEX

• Diarrhea-predominant IBS in women
• Priority Review
• Unanimous approval at November 16, 1999 FDA GI
  Drugs Advisory Committee
• Approved February 9, 2000
• First new treatment for IBS in decades

3
FDA Request for Advisory Meeting

• Present an overview of Risk Management Program
  for Lotronex
• Updated benefit and risk information for Lotronex

4
Risk Management for Lotronex

• Appropriate labeling
• Actively and effectively communicate new messages
• Evaluate reception of new messages

5
Fundamental Questions

• Has the benefit-risk profile for Lotronex
  changed?
• If there has been a change, what action is
  appropriate?

6
Has the Safety Profile Changed?

• Hepatic abnormalities
• No
• Ischemic colitis
• No
• Constipation
• Rare serious sequelae

7
Risk Management Program

• Builds on existing efforts
• Tailored to the evidence

8
Summary

• Positive benefit-risk
• Appropriate labeling modifications
• Tailored communication plan

9
Glaxo Wellcome Presentation AGENDA

• Introduction Richard Kent, MD
• IBS Burden of Illness Ian M. Gralnek, MD, MSHS
• Lotronex Safety Efficacy Allen Mangel, MD, PhD
• Risk Management Program Elizabeth Andrews, PhD,
  MPH J. S. Hull
• Conclusion Richard Kent, MD