Cellceutix’s Kevetrin Wins Rare Pediatric Disease Designation
The FDA granted rare pediatric disease designation to Cellceutix’s Kevetrin for the treatment of retinoblastoma.
The rare form of eye cancer begins in the retina and is potentially fatal if not diagnosed early. It is mostly found in children younger than 3.
With this designation, Cellceutix can apply for a rare pediatric disease priority review voucher, which can be redeemed to receive a priority review of a subsequent marketing application for a different product. The voucher also may be sold or transferred by the recipient.
In November, the agency granted the drug orphan drug status for the same indication. In Phase 1 trials, Kevetrin was shown to induce activation of p53, which plays a role in controlling cell mutations.