Press Releases

WASHINGTON, D.C. – Rep. Earl L. “Buddy” Carter (R-GA) today celebrated the Food and Drug Administration’s (FDA) decision to accept for review the resubmission of the New Drug Application for Stealth Biotherapeutics’ Barth Syndrome treatment elamipretide, with the goal of reaching a decision by September 26, 2025.

This comes after Rep. Carter sent a letter advocating for the FDA to approve the drug, which is saving lives in his home state of Georgia. Barth Syndrome is an exceedingly rare disease, impacting 150 known individuals in the United States and at least six individuals in the state of Georgia.

“I strongly believe in this drug’s potential to save and improve lives. A patient in Atlanta, Georgia told me that elamipretide has allowed him to live a life he could only have dreamed of before, and he is terrified that he could lose access. We cannot let that happen, and I applaud the FDA for its timely move today that brings elamipretide a step closer to an approval,” said Rep. Carter.

###