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BioWorld - Thursday, March 26, 2026
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Home » Adcom gives nod to Stealth’s elamipretide despite uncertainties
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Adcom gives nod to Stealth’s elamipretide despite uncertainties

Oct. 10, 2024
By Mari Serebrov
“This was worse than our national election,” Eric Peterson said as he explained his vote Oct. 10 concluding that Stealth Biotherapeutics Inc.’s elamipretide is effective in treating Barth syndrome, an ultra-rare mitochondrial disease that currently affects 129 males in the U.S. Peterson, a vice provost, senior associate dean and professor at the University of Texas Southwestern Medical Center, was one of 10 members of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) who came to that conclusion. Six others had a different opinion. Regardless of which way they voted, the panelists attested to how difficult the decision was.
BioWorld Regulatory Cardiovascular Rare disease Peptide U.S. FDA

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