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.
Shots For Shots Challenge
Show that everyone deserves a shot at life and to urge action to approve elamipretide!
How to Participate:
Film yourself taking your best shot— a shot of juice, coffee, water, or your drink of choice, a basketball, hockey, soccer shot, the sky’s the limit!
Post it to social media with the hashtag #ShotsForShotsChallenge
Nominate 3 others to participate within 12-24 hours.
Suggested video script:
We need the FDA to approve elamipretide for [insert name(s)].
So today I’m doing the Shots for Shots challenge because everyone taking elamipretide deserves a shot at life.
I’m going to [insert what type of shot you will do].
I’m going to challenge [name], [name], and [name] to join me.
Consider yourself challenged—you have 24 hours to finish this challenge.
[Do your shot]
Approve elamipretide!
Social media post description example:
#ShotsForShotsChallenge
Today I joined the #ShotsForShotsChallenge because the FDA still hasn’t approved elamipretide—the treatment that can save lives.
I’m taking my best shot so [friend/family name] can have a shot at life.
Every shot counts when the goal is giving kids a future. Let’s make sure the FDA hears us loud and clear: APPROVE ELAMIPRETIDE NOW.
Here's how to join:
- Take your shot (espresso, ginger, wheatgrass, etc; basketball, soccer, hockey, paper balls, photographs—the list goes on).
- Post your video or photo.
- Tag @fda, @drmakaryfda, @seckennedy, @potus, @hhsgov, and your members of Congress.
- Use hashtags: #ApproveElamipretide #ShotsForShotsChallenge
- Challenge as many friends as you want. They only have 24 hours to complete it (12 hours is preferred because September 1 is approaching quickly).
Because [insert name of affected individual] shouldn’t be waiting for their chance to live!
I challenge [list out names of people you want to challenge]
#approveelamipretide #shotsforshotschallenge
