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Product Profiles: Obesity - Pipeline stalls as regulatory requirements escalate
Datamonitor, July 2011, Pages: 72
Introduction
The failure of obesity therapies to meet US FDA safety demands has resulted in a series of negative regulatory responses and has prevented new approvals in obesity. This has left Xenical as the only long term therapy approved in the US and Europe. As obese patient numbers rise, Datamonitor assesses the potential of late stage pipeline products to capitalize on a growing, unmet clinical need
Features and benefits
- In depth analysis of late stage obesity pipeline products
- Assess the impact of recently withdrawn and discontinued obesity products
- Compare pipeline products by clinical attractiveness, commercial attractiveness and satisfaction of unmet need
- Track the successes and failures of currently marketed products, and consider their future performance
Highlights
Recently issued Complete Response Letters indicate that more evidence of long-term safety must be established for New Drug Applications in obesity. Orexigen reports that the Division of Metabolic and Endocrinologic Products is planning to hold a general advisory committee on cardiovascular assessment for obesity therapeutics in 2012
Lorqess and Qnexa both have challenging paths to approval that limit their commercial attractiveness. Unresolved safety issues have been the subject of Complete Response Letters which demonstrate the US Food and Drug Administration requires evidence of minimal risk before they can be approved
Novo Nordisk is now attempting to establish a presence in obesity by developing a higher dose of liraglutide and has shown weight loss in non-diabetics. Liraglutide’s GLP-1 mechanism avoids centrally acting side-effects that have been the cause of recent drug withdrawals. Pivotal Phase III trials are scheduled to begin in Q3 2011
Your key questions answered
- The updated, comprehensive obesity product profiles including latest clinical data and industry developments
- Understand the underlying reasons for Contrave’s suspension and the risk posed to other pipeline drugs
- Escalating regulatory demands have prevented new drug approvals. Assess where products are falling short what they will have to do gain approval
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