DOYLESTOWN, PA — Advent Therapeutics, Inc., a late-stage biotechnology company, announced that it recently received U.S. Food and Drug Administration (FDA) Rare Pediatric Disease Designation (RPDD) for its vitamin A metabolic and reparative respiratory drugs for the prevention of Bronchopulmonary Dysplasia (BPD) in premature infants.
FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases. Companies that receive approval for a New Drug Application (NDA) for a rare pediatric disease may be eligible for a voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product or sold to another sponsor for priority review of their marketing application. This program is intended to encourage the development of new drugs and biologics for the treatment of rare pediatric diseases.
“We are acutely focused on BPD as an area of high unmet medical need that presently has no FDA-approved therapies for prevention or treatment. The FDA Rare Pediatric Disease Designation is an important addition to the Orphan Drug designations previously granted by the US FDA and the European EMA for our vitamin A metabolic and reparative respiratory drugs,” said Dave L. Lopez, CEO of Advent Therapeutics.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News.