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FDA grants Cellceutix rare pediatric disease designation for Kevetrin to treat retinoblastoma
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Cellceutix has received rare pediatric disease designation from the FDA for Kevetrin to treat retinoblastoma, according to a press release.
“Receiving the rare pediatric disease designation strengthens our portfolio and adds to our belief that Kevetrin has the potential to provide a meaningful therapeutic benefit to children and families affected by retinoblastoma, where enucleation of the eye is often the only solution,” Leo Ehrlich, CEO of Cellceutix, said in the release.
The designation supplements the orphan drug designation the FDA granted in November.
With the designation, the company may also apply for participation in the FDA’s Rare Pediatric Disease Priority Review Voucher program, which is intended to incentivize the development of drugs for neglected diseases that have no adequate therapies, the release said.