Posted by Michael Wonder on 16 Apr 2019
Aprea Therapeutics receives FDA fast track designation and orphan drug designation for APR-246 for the treatment of myelodysplastic syndromes
16 April 2019 - Aprea Therapeutics today announced that the U.S. FDA has granted fast track designation to APR-246 for the treatment of patients with myelodysplastic syndrome having a TP53 mutation.
In addition, FDA has also granted orphan drug designation to APR-246 for treatment of MDS.
“The granting of fast track designation and orphan drug designation by FDA for APR-246 in TP53 mutated MDS underscores the significant unmet medical need in this disease,” said Christian S. Schade, President and Chief Executive Officer of Aprea. “With our Phase 3 clinical study in MDS underway, we look forward to continuing our productive dialogue with FDA and bringing APR-246 to patients as soon as possible.”
