MEDIPOST announced on November 22 that PNEUMOSTEM®, a preventive treatment for infants who are at high risk of developing Bronchopulmonary Dysplasia(BPD), has received a Fast Track Designation from the US FDA.
Bronchopulmonary Dysplasia(BPD) is a chronic lung disease which occurs in premature infants who have undergone artificial ventilation and oxygen therapy, which can cause serious sequela or even death, and currently there is no treatment available.
Fast Track Designation is one of the US FDA’s expedited pathways for new drug development and review. It is a regulatory fast-track designed to provide benefits for sponsors who are developing therapeutic solutions for serious illnesses for which there are no existing effective treatment options.
With Fast Track Designation, there can be more frequent meeting opportunities with the FDA during the clinical trial stage, with a variety of regulatory support and advice including a chance for qualifying for a ‘priority review’ which allows submission of approval documents on a case-by-case basis through a rolling review, which may result in expedited approval.
In particular, under a ‘priority review’, the approval review period may be shortened to less than 6 months compared to the generally expected period of 10 to 12 months, and over the past six years, the probability of being qualified for ‘priority review’ among fast track designated items, is over 90%.
PNEUMOSTEM® completed the US Phase 1/2 clinical trial this January and was awarded the Orphan Drug Designation in the US and Europe in 2013 and 2015, respectively.
A MEDIPOST official said, “We expect that the Fast Track Designation of PNEUMOSTEM® by the FDA will give us more flexibility to discuss the next phases of clinical trials and out-licensing opportunities outside Korea for a global expansion.”