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R&D Trends: Obesity - 2006-2011: Obesity's Lean Years
Datamonitor, May 2011, Pages: 40
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
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