R&D Trends: Obesity – 2006–2011: obesity’s lean years

Article by Ashlyn Brown

Modest efficacy outcomes 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 specifications in the light of recent withdrawals may see one more raft of discontinuations, as Datamonitor views the probabilities of the late-stage pipeline candidates expanding the obesity market as slim

Capabilities and benefits• Analyze the current obesity pipeline and identify trends that will shape its future• Establish the minimum acceptable and target item profiles required 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

HighlightsWith no new approvals because rimonabant in 2006 and right after the 2010 market withdrawal of sibutramine there is now only one prescription drug, Xenical (orlistat Roche), approved for the lengthy-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 stay in development

Three Complete Response Letters issued by the FDA in 2010-11 requesting further safety details from developers indicate that a a lot more solid clinical evidence base need to be established to gain approval in obesity. This is likely to drive the trend of growing patient enrollment numbers and trial duration for anti-obesity drugsAntidiabetic drugs with a weight-negative profile are establishing a location 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

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Your key questions answered• Datamonitor’s updated, comprehensive overview of the obesity pipeline• Comprehend 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 method and trial design

Table Of Contents

Executive SummaryStrategic scoping and focusDatamonitor important findingsRelated reports

OVERVIEWCatalystSummary

CLINICAL PIPELINE OVERVIEWObesity pipeline by phaseMode of effectMechanisms of actionCannabinoid receptor antagonistsSerotonergic drugsGlucagon-like peptide 1 agonistsCompany sort

TARGET Product PROFILEXenical (orlistat Roche)Pivotal trial resultsTarget product profile versus existing level of attainmentCLINICAL TRIAL Style IN OBESITYKey findingsEvolution of clinical trial design in obesityRegulatory guidance on main endpointsSecondary endpointsClinical trial size and durationSafetyComparatorsTypical Phase III trialFuture developments in clinical trial designElevated safety requirementsAlternative endpoints

Related Reports:Obesity Global Clinical Trials Evaluation, Q1, 2011 – http://www.reportsnreports.com/reports/60039-obesity-global-clinical-trials-review-q1-2011.html

Will Anyone Crack the Obesity Drug Marketplace? – http://www.reportsnreports.com/reports/60886-will-any person-crack-the-obesity-drug-market.html

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