Promedior Receives US Orphan Drug Designation for PRM-151 for the Treatment of Myelofibrosis

Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, has announced that FDA has granted an orphan drug designation for PRM-151, for the treatment of myelofibrosis, a serious, life-limiting cancer characterised by fibrosis of the bone marrow.

The FDA’s Office of Orphan Drug Products grants orphan drug designation to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 US patients. Orphan drug designation provides Promedior certain benefits, including 7 years of marketing exclusivity upon regulatory approval, a waiver of Prescription Drug User Fee Act (PDUFA) filing fees, the opportunity to apply for annual grant funding, clinical trial design assistance, and tax credits for clinical research costs.

"Orphan drug designation is a significant step forward in the development of PRM-151, and we are excited to continue advancing PRM-151 to better meet the needs of patients with myelofibrosis," said Suzanne L. Bruhn, PhD, President and CEO of Promedior. "Based on the encouraging clinical results reported to date in myelofibrosis patients we believe that PRM-151’s novel mechanism of action is compelling with its potential to target and reverse the fundamental bone marrow fibrosis that underlies patients’ disease."