In April, Prometic Life Sciences Inc. announced it would be submitting a Biologics License Application to the FDA for treatment of hypoplasminogenemia.
The company’s therapy has already been listed with Orphan Drug and Fast Track Designation, and there is good reason to believe that the application will be accepted.
Within the application, the company provided data collected from a study conducted within the United States. It contains information from over 900 million medical claims and shows that approximately 2,100 patients have needed medical care for some sort of plasminogen deficiency within the past nine months.
That shows that while hypoplasminogenemia may be rare, there are hundreds of other individuals who could benefit from the treatment that their company could provide.
The application also lays out the results from the phase 2/3 clinical trial of their plasminogen, which showed a success rate of 100 percent. That’s hard to argue with.
Hypoplasminogenemia is usually most severe in children. Additionally, the analysis completed in the U.S. showed that most of those seeking treatment were under the age of 18. So, within the application, Prometic Life Sciences also asked for a pediatric designation for the treatment.
What is perhaps most exciting about this new treatment is that the company is claiming it will be “cost effective.” While nothing is for certain yet, this is hopeful news for the hypoplasminogenemia community.
Keep an eye out on this new treatment possibility, and any updates that may come from the FDA.
Read more about Prometic Life Sciences and the application here.
