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.”
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