Promedior's PRM-151 drug for the treatment of myelofibrosis has been granted FDA orphan drug designation

Promedior’s Myelofibrosis Drug Receives FDA Orphan Drug Designation

In Regulation & Government by CecileLeave a Comment

Promedior’s PRM-151 drug for the treatment of myelofibrosis has been granted FDA orphan drug designation

Today, Promedior, a biotechnology company, announced in a press release that the US FDA has given them orphan drug designation for their experimental drug PRM-151, for the treatment of myelofbrosis, a type of leukemia that interferes with the bone marrow’s ability to produce blood cells.

This coveted orphan designation gives Promedior a number of advantages with respect to the development of the drug. These include a seven year period of exclusive marketing rights, tax cuts for clinical trial expenses and opportunities to apply for federal grants.

Dr.Suzanne Bruhn, the President and CEO of Promedior, has said of the news that “…we are excited to continue advancing PRM-151 to better meet the needs of patients with myelofibrosis.”

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’ diseaseDr.Suzanne Bruhn, President and CEO of Promedior

The disease affects about 18,000 people a year in the US alone, and it usually affects people above the age of 60.

The only possible way of curing the disease is through repeated bone marrow transplants. This reverses the fibrosis process in the bone marrow. This, however, only works on a very small proportion of the patient population. Aside from this, any other therapies only treat the symptoms.

Phase 2 trials for PRM-151 have already taken place with positive results. The next stage for the drugs development will be a large scale phase 3 trial.

Read more about it here: Promedior Receives U.S. Orphan Drug Designation for PRM-151 for the Treatment of Myelofibrosis

Leave a Comment