Rep. Earl L. “Buddy” Carter (R-GA) has announced that the Food and Drug Administration (FDA) will review the resubmission of Stealth Biotherapeutics’ New Drug Application for elamipretide, a treatment for Barth Syndrome. The FDA is expected to reach a decision by September 26, 2025.
The announcement follows a letter from Rep. Carter to the FDA urging approval of elamipretide, which he says is making a difference for patients in Georgia. Barth Syndrome is a rare disease affecting about 150 people nationwide, including at least six individuals in 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.
Rep. Carter has held his seat through several election cycles, winning the 2024 general election against Patti Hewitt with 62% of the vote and defeating other challengers in previous years as well.
