SPARC Bags USFDA Rare Pediatric Disease Priority Review Voucher for Sezaby

In an official disclosure, SPARC stated that the PRV has been granted in association with the FDA approval of Sezaby®. The company noted that a press release on the development would be issued after the regulatory intimation.

According to the company, a Priority Review Voucher is a tradable incentive granted by the US FDA to encourage the development of therapies for rare pediatric diseases. The voucher can be redeemed to obtain a priority review for a future, separate drug application, thereby significantly reducing review timelines.

Announcing the development, SPARC said the grant of the PRV highlights its continued focus on addressing high unmet medical needs, particularly in vulnerable patient populations. The company also stated that it intends to utilize the voucher to accelerate its research and development pipeline, allowing faster advancement of therapies to patients.

Commenting on the milestone, Anil Raghavan, Chief Executive Officer of SPARC, said, "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. 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."

Sezaby® is a benzyl alcohol- and propylene glycol-free formulation of phenobarbital sodium powder for injection. The drug has been approved by the US FDA for the treatment of neonatal seizures, a serious and potentially life-threatening condition in newborns.

Sun Pharma Advanced Research Company Ltd is a pharmaceutical company focused on advancing global standards of care through innovation in therapeutics and drug delivery, while aiming to improve affordability and access to treatments worldwide.