Sun Pharma Advanced Research Company (SPARC) announced that the United States Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Priority Review Voucher (PRV) associated with the approval of Sezaby.
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases, that can be redeemed to receive a priority review for a subsequent, separate drug application.
“Receiving this Priority Review Voucher is a significant milestone for SPARC and a testament to our commitment to addressing the urgent, unmet needs of patients,” said Anil Raghavan, CEO of SPARC. “This award not only recognizes the therapeutic value of Sezaby but also provides SPARC with additional strategic flexibility to accelerate our pipeline development to bring more therapies to patients faster.”