Summary
Introduction
Modest efficacy results and lingering safety concerns have meant that developers of obesity drugs have failed to convince regulators of their risk-benefit profiles. The continued escalation of safety requirements in the light of recent withdrawals might see another raft of discontinuations, as Datamonitor views the chances of the late-stage pipeline candidates expanding the obesity market as slim
Features and benefits
• Analyze the current obesity pipeline and identify trends that will shape its future
• Establish the minimum acceptable and target product profiles necessary for success in the obesity market
• Assess the challenges faced in treating obesity and the future direction for obesity therapy
• Provide insight into clinical trial design in obesity
Highlights
With no new approvals since rimonabant in 2006 and after the 2010 market withdrawal of sibutramine there is now only one prescription drug, Xenical (orlistat; Roche), approved for the long-term management of obesity in the US, France, Germany, Italy, Spain, and the UK. Of the five drugs that were in Phase III in 2009, all remain in development
Three Complete Response Letters issued by the FDA in 2010-11 requesting further safety information from developers indicate that a more solid clinical evidence base must be established to gain approval in obesity. This is likely to drive the trend of increasing patient enrollment numbers and trial duration for anti-obesity drugs
Antidiabetic drugs with a weight-negative profile are establishing a place in all phases of the obesity pipeline. Novo Nordisk and Eli Lilly both have glucagon-like peptide-1 agonists (GLP-1s) in development for obesity. The most advanced of which is liraglutide, in Phase III trials for obesity
Your key questions answered
• Datamonitor’s updated, comprehensive overview of the obesity pipeline
• Understand how recently issued Complete Response Letters are shaping the obesity pipeline
• Escalating regulatory demands have prevented new drug approvals and will continue to influence developmental strategy and trial design
Table of Contents
Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Obesity pipeline by phase
Mode of effect
Mechanisms of action
Cannabinoid receptor antagonists
Serotonergic drugs
Glucagon-like peptide 1 agonists
Company type
TARGET PRODUCT PROFILE
Xenical (orlistat; Roche)
Pivotal trial results
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN OBESITY
Key findings
Evolution of clinical trial design in obesity
Regulatory guidance on primary endpoints
Secondary endpoints
Clinical trial size and duration
Safety
Comparators
Typical Phase III trial
Future developments in clinical trial design
Elevated safety requirements
Alternative endpoints
THE FUTURE OF TREATMENT IN OBESITY
Patient segmentation
Combinations
Prevention
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Contributing experts
Conferences attended
Report methodology
