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FDA Grants J&D Pharmaceuticals Rare Pediatric Disease Designation and Orphan Drug Designation

FDA Grants J&D Pharmaceuticals Rare Pediatric Disease Designation and Orphan Drug Designation

J & D Pharmaceuticals has just received FDA orphan drug designation for its medications (JD-004 and JD-005) for treatment of the ultra-rare pediatric disease, Hutchinson Gilford Progeria Syndrome (HGPS) also known as Progeria as well as Related Laminopathies. The only FDA approved medication for Progeria is lonafarnib which resulted in a 90 million dollar rare pediatric voucher that was split between the Progeria Research Foundation and a pharmaceutical company. J & D Pharma also was granted a rare pediatric disease voucher designation by the FDA. 

According to J & D’s CEO, Joel Ross, “This is a milestone that was 9 years in the making.” Ross further added,  “the active moiety of JD-004 and JD-005 has already been proven safe and effective in slowing the aging process in Progeria mice. ” Clinical studies are expected to start in 2025. For further information, please contact jross@jdpharmaceuticals.com


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Email: jross@jdpharmaceuticals.com

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