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Vyleesi’s Approval Delayed By Blood Pressure Study Conducted During NDA Review

 
• By Sue Sutter

Although the US FDA first recommended a dedicated ambulatory blood pressure monitoring study in March 2017, AMAG did not move forward with such a trial until late 2018 and only after the agency said the results were needed prior to approving bremelanotide, the Pink Sheet's latest Drug Review Profile finds.

Blood Pressure, Woman - Image
A blood pressure study delayed the approval of AMAG's Vyleesi • Source: Shutterstock

US Food and Drug Administration approval of AMAG Pharmaceuticals Inc.'s Vyleesi (bremelanotide) for hyposexual sexual desire disorder was delayed three months by the need to conduct a dedicated ambulatory blood pressure monitoring trial during the review – a study that the agency first recommended more than two years before approval.

Elevation in blood pressure and decreases in heart rate were seen during ambulatory BP assessments in a Phase II study...

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