Medipost said that the U.S. Food and Drug Administration has given a fast- track designation for Pneumostem, a bronchopulmonary dysplasia treatment for preterm infants.
|Medipost headquarters in Seongnam, Gyeonggi Province.|
The fast-track designation comes after the FDA gave an orphan drug designation for the drug in 2014. The company has also completed phase 1 and 2 clinical trials in the U.S. in January this year.
FDA’s fast-track designation targets drugs that are likely to address severe diseases or unmet medical needs. The designation can shorten the time for submitting a new drug application as it allows companies to work closely with the FDA on essential issues such as consultation on clinical design, advice on obtaining licensed data, and organizing permit data.
The classification also makes companies eligible for a rolling review, which allows them to submit the necessary data step by step, while valid clinical data may also be subject to a priority review designation upon application for a permit review or submission of supplemental data.
<© Korea Biomedical Review, All rights reserved.>