Cellceutix’ Kevetrin gets Rare Pediatric Disease designation from FDA

US biotech firm Cellceutix Corp (OTCQB: CTIX) revealed that the US Food and Drug Administration has granted Rare Pediatric Disease designation for its Kevetrin (thioureidobutyronitrile) for the treatment of retinoblastoma, a rare form of eye cancer that begins in the retina, the light sensitive nerve tissue that lines the back of the eye.

Retinoblastoma is most generally found in children, usually before the age of three, and rarely found in adults. It is sight threatening and potentially fatal if not diagnosed early. The rare pediatric disease designation supplements the Orphan Drug Designation granted by the FDA to Kevetrin for retinoblastoma, as announced on November 23, 2015.

The designation of Rare Pediatric Disease provides the opportunity to apply for participation in the FDA's Rare Pediatric Disease Priority Review Voucher Program. The program is intended to incentivize development of drugs for neglected diseases where no adequate therapies exist. Due to a provision triggered earlier this year, the voucher program will be up for review and reauthorization by Congress, as it is scheduled to end early in 2016. While the voucher program has wide support, there are no assurances to reauthorization in whole or changes that could be made.