1. Pink Sheet

AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input

 
• By Sue Sutter

US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.

Drug Review Profile regular column
Patient Input Helped Inform US FDA Views On Endpoints, Clinical Outcome Assessments

The US Food and Drug Administration allowed the endpoints for AMAG Pharmaceuticals Inc.'s Vyleesi (bremelanotide) Phase III program to evolve as the regulator gained more knowledge about hypoactive sexual desire disorder and experience with the clinical outcome assessments proposed for use.

The agency grew more comfortable with the sponsor’s plans for measuring treatment-related changes in desire and distress thanks to a patient-focused drug development meeting and a scientific workshop

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