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GAINESVILLE, GA - Today, Congressman Andrew Clyde (GA-09) released the following statement in reaction to the U.S. Food and Drug Administration (FDA) granting accelerated approval to Stealth Biotherapeutics' Barth Syndrome treatment, Forzinity (elamipretide HCl).
"I'm thrilled with the FDA's recent decision to grant accelerated approval to elamipretide," said Clyde. "This matter is deeply personal to the Ninth District, as one of my constituents, Hope Filchak, depends on elamipretide as a lifeline in her battle with a rare mitochondrial disorder. I promised Hope's parents, Ben and Caroline, that I would do everything in my power to help their effort for this critical drug to receive the FDA's approval. This advocacy work included adding an elamipretide-related amendment in the FY26 appropriations process and speaking directly with HHS Secretary Robert F. Kennedy Jr. about Hope's case. I'm incredibly pleased by the FDA's approval of this life-saving drug - delivering remarkable news to Hope, her family, and Americans across the country battling rare mitochondrial diseases."
"Congressman Clyde is a great man and a faithful and effective leader," said Ben and Caroline Filchak, parents of Hope Filchack, who takes elamipretide through an expanded access program. "He truly cares about the people he serves, and that has been evident in the way he has walked with us through our fight to get the trial drug elamipretide approved by the FDA. He has sent letters to HHS and FDA, had conversations with leadership, made phone calls, and done everything in his power to support this effort."
"What stands out most to me about him, however, is his deep faith. He shared with us that he and his staff prayed over a message they sent to HHS Secretary RFK Jr., and that he regularly prays for Hope and our family. Throughout this journey, he consistently checked in on us, and we knew he was fighting not only for our daughter and others who rely on this drug, but also for what is right. Congressman Clyde is a humble, faithful leader who truly cares about the people he serves and will fight diligently on their behalf. We are deeply grateful for him," Ben and Caroline Filchak added.
The FDA's major decision comes after months of Rep. Clyde's advocacy. In June, Rep. Clyde added report language (page 93) to the FY26 Agriculture, Federal Drug Administration, and Rural Development appropriations bill expressing concern about the potential loss of access to elamipretide and requesting the FDA provide a report detailing a transparent overview of its review process for the drug.
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