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3DBio Therapeutics has won a unique designation from FDA. The New York-based company was granted a Rare Pediatric Disease designation for AuriNovo, an investigational combination product for reconstruction of the outer ear in patients with microtia.
Microtia is a rare congenital disorder causing the outer ear (auricle) to be smaller than typical, misshapen, and sometimes missing at birth; most cases only affect one ear.
The firm’s AuriNovo combination product incorporates the patient's own auricular cartilage cells into a 3D-bioprinted, living, full-sized ear construct designed to replace the patient's microtia-affected ear. AuriNovo is then implanted under the patient's skin.
FDA’s Rare Pediatric Disease designation provides incentives to advance the development of drugs and biologics to treat rare diseases. Through FDA's Rare Pediatric Disease Priority Review Voucher Program a sponsor who receives marketing approval for a product with a Rare Pediatric Disease designation may be eligible for a voucher that can be redeemed to obtain priority review for any subsequent marketing application.
"We are pleased to have received Rare Pediatric Disease designation, as it highlights the seriousness of microtia and the impact it has on children born with the condition," Daniel Cohen, PhD, CEO of 3DBio Therapeutics, said in a release.