Nda 21 200
Sponsored Links
This presentation is the property of its rightful owner.
1 / 9

NDA 21-200 PowerPoint PPT Presentation


  • 88 Views
  • Uploaded on
  • Presentation posted in: General

Zelmac ™ (tegaserod). NDA 21-200. Gastrointestinal Advisory Committee Meeting Gaithersburg, Maryland June 26, 2000. Zelmac ™ (tegaserod). Introduction. Mathias Hukkelhoven, PhD Vice President Head, US Drug Regulatory Affairs Novartis Pharmaceuticals Corporation. Proposed Indication.

Download Presentation

NDA 21-200

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Zelmac™

(tegaserod)

NDA 21-200

Gastrointestinal Advisory Committee Meeting

Gaithersburg, MarylandJune 26, 2000


Zelmac™

(tegaserod)

Introduction

Mathias Hukkelhoven, PhD

Vice PresidentHead, US Drug Regulatory Affairs

Novartis Pharmaceuticals Corporation


Proposed Indication

Zelmac™ (tegaserod) is indicated for the treatment of irritable bowel syndrome (IBS) in patients who identify abdominal pain/ discomfort and constipation as their predominant symptoms.


Irritable Bowel Syndrome

  • Symptoms

    • Abdominal pain or discomfort

    • Bloating

    • Altered bowel function

      • Frequency of bowel movements

      • Stool consistency

  • Chronic or recurrent course

  • Severity ranging from mild to severe/intractable

  • Symptoms due to disturbances in GI motility and enhanced visceral sensitivity

  • Highly prevalent and associated with significant disability and healthcare costs


Spectrum of IBS

Patients can have different bowel symptoms over time

Diarrhea

Alternating

Constipation


TegaserodPharmacologic Profile

  • Potent and selective 5-HT4 receptor partial agonist

  • Modulates normal and impaired motility throughout the gastrointestinal tract

  • Modulates intestinal chloride/water secretion

  • Inhibits visceral sensation upon colorectal distension

  • Lacks cardiovascular, renal, respiratory, CNS, and endocrine effects


Regulatory Background

  • No clinical guidelines or medical consensus regarding appropriate outcome measures in IBS

  • Novartis conferred with medical experts and had several interactions with FDA regarding outcome measures for the 3 tegaserod phase III studies

  • Specific consultation with GI Division following analysis of first phase III study (B351) and prior to the unblinding and analysis of the remaining 2 phase III studies (B301 and B307)


TegaserodClinical Profile

  • Totality of data derived from 4,000 subjects of whom 3,000 IBS patients were enrolled in clinical studies, support the following clinical profile

    • Tegaserod 12 mg/d (6 mg BID) is effective in relieving abdominal pain or discomfort, bloating, and constipation in patients who identify abdominal pain or discomfort and constipation as their predominant symptoms

    • Tegaserod is safe and well tolerated


Agenda

Irritable Bowel Syndrome . . . . . . . . . . Arnold Wald, MD

5-HT4 Receptor Activation . . . . . . Michael Camilleri, MD

Efficacy and Safety of Tegaserod . . . . . . . . . . . . . . . . . Martin Lefkowitz, MD

Preclinical Findings . . . . . . . . . . . . . Philip Bentley, PhD

Review of Data on Ovarian Cysts . . . . . . . . . . . . . . . . . . . . . .Bruce Carr, MD

Closing Remarks . . . . . . . . . . . . . . . .Sidney Cohen, MD


  • Login