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NDA 21-200

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

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  1. Zelmac™ (tegaserod) NDA 21-200 Gastrointestinal Advisory Committee Meeting Gaithersburg, MarylandJune 26, 2000

  2. Zelmac™ (tegaserod) Introduction Mathias Hukkelhoven, PhD Vice PresidentHead, US Drug Regulatory Affairs Novartis Pharmaceuticals Corporation

  3. 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.

  4. 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

  5. Spectrum of IBS Patients can have different bowel symptoms over time Diarrhea Alternating Constipation

  6. 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

  7. 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)

  8. 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

  9. 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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