A New Drug is Approved
A novel recombinant coagulation factor IX bound to recombinant albumin, Albutrepenonacog alpha has obtained marketing authorization of the European Commission, as CSL Behring has recently announced.
The commission decision is based on results of PROLONG-9FP clinical trial program, including multicenter phase I-III trials that assessed safety and efficacy of the drug in children and adults (1 to 61 years) with hemophilia B (factor IX level ≤ 2%).
Albutrepenanocog alpha – is the first in class long-acting orphan drug for treatment and prevention of bleedings in patients with hemophilia B (inherited factor IX deficiency) in children and adults. It proides a high level of protection, supporting the activity of factor IX at a level above 5% for 14 days and more in most patients. As a result, an interval between infusions in patients of ≥12 years old may be as long as 2 weeks, while maintaining superior bleeding control. It also helps significantly reduce the amount of international coagulation factor IX units, required for preventive therapy.
The drug is approved by the US Food and Drug Administration (FDA).
The launch of that novel first in class orphan drug in the European market is planned in a few months. As albutrepenonacog alpha is an orphan drug, a decision on approval of patent protection of the drug in the European Union market for 10 years has been taken.