2014 Promedior Fast Track
The FDA has granted Fast Track designation to PRM-151 for the treatment of myelofibrosis (MF), a serious, life-limiting cancer characterized by fibrosis of the bone marrow. This Fast Track designation covers Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, and Post-Essential Thrombocythemia Myelofibrosis.
The FDA grants Fast Track designation to a product that is intended to treat a serious condition and that has demonstrated the potential to address an unmet medical need. The advantages of Fast Track designation include actions to expedite development and FDA review including opportunities for frequent interactions with the FDA review team and eligibility for priority review depending on clinical data at the time of Biologics License Application submission. PRM-151 was awarded orphan drug designation for myelofibrosis in September 2014. Click here to read the full release.