On their Q124 earnings call, Sarepta noted that they anticipated a draft Elevidys label imminently.?They have since entered a quiet period.
Does this mean an FDA decision is coming ahead of the official June 21 action date for Elevidys?
Recall, Sarepta received accelerated approval for Elevidys close to a year ago (June 2023), but has asked FDA for full approval and a label expansion based, in part, on data from EMBARK as well as ENVISION, a study conducted in older, non-ambulatory patients with Duchenne.
Three label variables are at play, making for a combination lock of potential outcomes when FDA makes its announcement:
1. The current accelerated label is for walking Duchenne patients (ambulatory) but Sarepta also wants approval in patients who are no longer walking.
2. The current accelerated approval label covers patients ages 4-5 only, whereas Sarepta wants approval without age restrictions.
3. Regardless of age or ambulatory status, Sarepta also wants conversion to a full approval for all Duchenne populations.
Sarepta isn’t shy about asking for approval where they do not have clear data.?This means whatever decision FDA makes, it’s likely to be mosaic and not binary.
Stay tuned, the answers could come at any point in the next six weeks leading up to June 21, but all indications point to the sooner side of that window.
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