One Minute, Real Impact: Help Advocate for Elamipretide Approval

I’m writing today with an urgent request that could change lives—including mine.

The FDA is currently considering approval of a treatment called Elamipretide, which has helped stabilize key functions for people living with primary mitochondrial disease—a rare, progressive, and often devastating condition. I’ve personally benefited from this treatment, which has helped me remain more independent, contribute to my family, and avoid costlier, more intensive care.

But despite a positive recommendation from the FDA’s own advisory committee, the agency has not yet approved Elamipretide. This delay puts vital progress—and people—at risk.

If you want to understand the stakes, I’ve written more here:
👉 Read my KevinMD article

If you’re unfamiliar with terms like mitochondrial disease, orphan drug, or FDA advisory committee, I explain them briefly here:
👉 What These Terms Mean

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Here’s how you can help:

➡️ Visit the FDA’s feedback page:
https://www.fda.gov/news-events/interactive-and-social-media/fda-direct-ask-question

Then follow these simple steps:
1. Under “Topic,” select “Drugs and Biologics”
2. Under “I am a,” choose the category that best describes you (e.g., Patient, Caregiver, Advocate, Concerned Citizen)
3. In the message box (250 characters), paste this message:

Please approve Elamipretide for primary mitochondrial disease. The FDA advisory committee recommended it. As an orphan drug, this treatment deserves wise and timely action. Patients can’t afford more delays. #ApproveElamipretide

Your message goes straight to the FDA. It takes less than a minute—and it matters more than you know.

Thank you from the bottom of my heart.