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Hot Topics: Obesity - The US FDA and cardiovascular risk analysis: the AdComm Cometh

Description

Introduction

Datamonitor proposes that the guidelines for developing obesity therapeutics are going to be overhauled in 2012, with major repercussions for developers. Trial requirements are likely to intensify substantially, the prospect of which has already pushed one developer to suspend US development until clear regulatory pathways are established.

Features And Benefits

• Profile of key areas of regulatory stance on diabetes drug cardiovascular safety, and their relevance to future obesity scenarios
• Examination of alternative scenarios where diabetes precedents may be less relevant
• Identification of issues requiring longer term consideration, and likely interim fixes
• Clinical and commercial considerations for the implementation of new guidelines, and respective ramifications

Highlights

Evolution of cardiovascular risk analysis in diabetes should provide useful blueprints for seismic shifts in obesity risk assessment. Cardiovascular risk assessment requirements will directly impact study populations, trial size and duration of study, while the very purpose of obesity therapies may ultimately be revisited and redefined.

The FDA is likely to provide companies mid-regulatory review with a degree of flexibility. Datamonitor believes that this may not improve their candidates’ long term prospects, but might explain their eagerness to resubmit their new drug applications beyond obvious and conventional commercial competitiveness.

Diabetes will not provide all the answers for obesity risk/benefit analysis, but it does provide a starting point. Likely frameworks will dramatically increase future development costs, but by the same token, these standards provide a far clearer picture of acceptable risk benefit profiles - capable of attracting developers in the longer term.

Your Key Questions Answered

• A unique Datamonitor view of the regulatory landscape in obesity, providing in depth background for a much talked-about market sector
• Independent, objective analysis of a topic traditionally dominated by invested stakeholders.
• Pan-disease contextualisation, providing pragmatic assessments and realistic scenarios.

Table of Contents

Executive Summary

   Strategic scoping and focus
   Datamonitor key findings
   Related reports
OVERVIEW
   Catalyst
   Summary
OBESITY, DIABETES, CARDIOVASCULAR RISK, AND THE US FDA
   Obesity and type 2 diabetes cardiovascular safety: compare and contrast
      Enhancing identification of safety signals prior to approval
      Demonstrating cardiovascular benefit versus ruling out unacceptable risk
      Realistic thresholds for unacceptable risk
      Suitable primary endpoints for cardiovascular risk
      Size and duration for long-term cardiovascular trials
      Suitable trial populations
      Comparators and controls
      Intent to treat versus per protocol analysis
      Concurrent management of other cardiovascular risk factors
      Risk rule-out requirement in the absence of signals from previous trials, and pre- or post-approval setting
      Applicability to currently marketed products
   Implementation considerations
      Aspects of timing
      Handling of products at different stages of development
      Future challenges in diabetes and considerations for obesity
BIBLIOGRAPHY
   Journal papers
   Websites
   Institution reporting and presentations
   Datamonitor reports

Appendix

   Report methodology
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