AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input
Executive Summary
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.
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Vyleesi Cinical Development Timeline
Chronicle of the development and review of AMAG Pharmaceuticals’ bremelanotide for premenopausal women with acquired, generalized hypoactive sexual desire disorder.