Synlogic, Inc. announced that SYNB1934 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the potential treatment of phenylketonuria (PKU). Synlogic also received RPDD for SYNB1353 for the potential treatment of homocystinuria (HCU) in December 2022. The FDA grants RPDD for serious and life-threatening diseases that primarily affect individuals from birth to 18 years old and fewer than 200,000 persons in the U.S. RPDD means that the sponsor may be entitled to receive a pediatric priority review voucher (pPRV) if the drug is initially approved for that rare childhood disease.
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- Synlogic, Inc. Receives Rare Pediatric Disease Designation from FDA for SYNB1934 for Phenylketonuria