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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.

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Nda 21 200

Zelmac™

(tegaserod)

NDA 21-200

Gastrointestinal Advisory Committee Meeting

Gaithersburg, MarylandJune 26, 2000


Introduction

Zelmac™

(tegaserod)

Introduction

Mathias Hukkelhoven, PhD

Vice PresidentHead, US Drug Regulatory Affairs

Novartis Pharmaceuticals Corporation


Proposed indication

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

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

Spectrum of IBS

Patients can have different bowel symptoms over time

Diarrhea

Alternating

Constipation


Tegaserod pharmacologic profile

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

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)


Tegaserod clinical profile

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

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


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