Description
Introduction
While two developers are pressing ahead with resubmission plans, a third is disputing US regulator handling and suspending US commercialisation, citing a potentially game changing review of regulatory expectations in the obesity field. This analysis examines the background, current situation and future prospects for these obesity developers at this critical time.
Features And Benefits
• Step-by-step appraisal of complete response letter requirements for Qnexa, Lorqess and Contrave
• Assessment of planned approaches taken in response to regulatory demands, including evaluation and interpretation of corporate pronouncements
• Contextualisation of strategic and tactical approaches against broader regulatory and corporate considerations
• In depth assessments of likely outcomes and ramifications for Vivus, Arena and Orexigen
Highlights
Vivus appears to have contingencies aimed at securing approval for Qnexa prior to regulatory change. These feature high risk strategies, however, with no commercialisation partner for Qnexa, and mixed opportunities for its other late stage candidate, short term regulatory success may be turning into a commercial imperative.
Arena has chosen to implement some short cuts to regulatory resubmission for Lorqess, and it is being realistic about likely time-requirements. However, even with pre-approval financial support from Eisai, broader operations are highly reliant on regulatory success, and long term viability is still threatened by guideline re-evaluation.
Orexigen is disputing regulator requirements and putting commercialisation on ice. Its partnering agreement with Takeda and potential for imminent shifting goalposts make this approach as pragmatic and reasoned as earlier regulatory dealings. However, it is unsurprising that the company is actively considering other commercialisation opportunities.
Your Key Questions Answered
• Identify the key components of each company’s regulatory requirements and their relative significance
• Contextualise tactics through understanding motivations driving broader considerations, and predict directional shifts by pinpointing key milestones
• Assess prospects and timing of ultimate US regulatory success or failure through in-depth understanding the broader regulatory machinations at work
Table of Contents
Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
VIVUS, ARENA, AND OREXIGEN US FDA COMPLETE RESPONSE LETTER ACTIVITIES
Qnexa (phentermine and topiramate; Vivus, Inc.)
Assessment of topiramate' s and phentermine/topiramate' s teratogenic potential
Evidence that heart rate elevation does not increase major adverse cardiovascular event risk
Lorqess (lorcaserin; Arena Pharmaceuticals)
Diagnostic uncertainty in classification of mammary masses in female rats
Unresolved exposure-response relationship for lorcaserin-emergent mammary carcinoma
Method of action and safety margin for astrocytomas
Labeling and the Controlled Substances Act
Submission of BLOOM-DM data
Contrave (naltrexone and bupropion; Orexigen Therapeutics)
Currently available data
Demonstrating cardiovascular risk does not adversely affect Contrave’s benefit-risk profile
BIBLIOGRAPHY
Journal papers
Websites
Institution reporting and presentations
Datamonitor reports
Appendix
Report methodology
