The FDA has refused Stealth BioTherapeutics’ request to reconsider its application for elamipretide—despite earlier indications from FDA reviewers that such a request was appropriate. Instead, the FDA has instructed Stealth to resubmit under the accelerated approval pathway with a 6-month review timeline, the longer of two options. This delay, coupled with financial constraints facing Stealth, puts the future of elamipretide—and the Expanded Access Program (EAP) through which patients currently receive it—at serious risk. Without immediate action or a shortened review, access could end as soon as September, leaving individuals with Barth syndrome and other mitochondrial diseases without the only treatment shown to improve symptoms.
We are calling on the community to advocate by participating in Elamipretide Action Week and the social media #ShotsForShotsChallenge. We have outlined a week of ways to participate in advocacy from anywhere, from August 18 through 22, to convey the urgency and to keep elamipretide at the forefront. Every voice matters—together, we can push for the urgent action needed to preserve access to this critical therapy.
Friends & Family Friday
August 22 is Friends & Family Friday
Personal stories are powerful. By sharing real experiences from those living with mitochondrial conditions, we can show the urgency for FDA action on elamipretide and fill social media feeds with the faces and voices behind this cause.
Take action: Use the provided template to share your story, then ask your friends and family to share it far and wide. Every post helps amplify our message and reach more decision-makers.
Template available here.
Remember to use these hashtags:
#approveelamipretide #barthprogress #fdaactnow #barthsyndrome #raredisease #mitochondrialdisease #mito
