1. Pink Sheet

Sarepta’s ESSENCE Trial Gets FDA Panel Nod For Protocol Changes

 
• By Sue Sutter

US agency’s experts unanimously support allowing use of in-dwelling ports to aid infusions in trial of two Duchenne muscular dystrophy compounds, while also endorsing the two-year, double-blind, placebo-controlled design, which was influenced by the clinical experience with Exondys 51 (eteplirsen).

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The US FDA’s external advisors gave a thumbs up to allowing use of in-dwelling ports in a Sarepta Therapeutics Inc. Duchenne muscular dystrophy study, endorsing the trial’s placebo-controlled design in the process.

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