Promedior Receives U.S. Orphan Drug Designation For PRM-151 For The Treatment Of Myelofibrosis
9/2/2014 11:28:09 AM
LEXINGTON, Mass.--(BUSINESS WIRE)--Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation for PRM-151, for the treatment of myelofibrosis, a serious, life-limiting cancer characterized 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 U.S. patients. Orphan drug designation provides Promedior certain benefits, including seven 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.
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