Advent Therapeutics received FDA rare pediatric disease designation for its vitamin A metabolic and reparative respiratory drugs for the prevention of bronchopulmonary dysplasia (BPD) in premature infants.
BPD is a rare disease and the most common serious complication facing premature infants, resulting in significant morbidity and mortality. Annually, in both the U.S. and Europe, there are approximately 100,000 premature infants at-risk for BPD and many more in Asia-Pacific, Latin America and throughout the world.
“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,” Dave Lopez, CEO of closely held Advent, said in a statement.
“The FDA rare pediatric disease designation is an important addition to the orphan drug designations previously granted by the FDA and the European Medicines Agency for our vitamin A metabolic and reparative respiratory drugs,” he added.
