Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the United States Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Priority Review Voucher (PRV) linked to the approval of Sezaby®. The development marks a meaningful regulatory milestone for SPARC and strengthens the company’s strategic position in advancing therapies for rare pediatric conditions.
The PRV programme is designed to incentivise innovation in treatments for rare pediatric diseases. Such vouchers are awarded by the United States Food and Drug Administration and can be traded or redeemed to obtain a priority review for a future, separate drug application. Priority review status shortens the FDA’s standard review timeline, potentially enabling faster regulatory decisions for subsequent products in a company’s pipeline.
Sezaby® receiving approval and the associated PRV highlights the therapeutic relevance of the drug in addressing unmet medical needs in pediatric care. The voucher provides SPARC with additional flexibility, as it can either be used internally to accelerate the review of another candidate or monetised through a sale to other pharmaceutical companies, a route often taken to fund further research and development.
