FDA recently approved Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the treatment of hemophilia B. Here are the top 6 facts to know about Idelvion.
FDA recently approved Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the treatment of hemophilia B.
Idelvion, manufactured by CSL Behring, is the first coagulation factor-albumin fusion protein product to be approved by FDA, and the second Factor IX fusion protein product approved in the US that is modified to last longer in the blood.
Related: FDA OKs modified antihemophilic factor for hemophilia A
“The approval of this long-acting recombinant factor IX therapy for hemophilia B is vital, as physicians need more options to help their patients effectively and safely manage their bleeding disorder,” said Elena Santagostino, MD, PhD, Professor in the Medical School of Clinical and Experimental Hematology at the University of Milan/IRCCS Maggiore Hospital, and lead investigator of the PROLONG-9FP clinical development program.
Here are the top 6 facts to know about Idelvion:
1. Idelvion’s anticipated availability is late March, 2016.
2. The drug will be available as 250 IU, 500 IU, 1000 IU, and 2000 IU powder and solvent for solution for injection. It may be self-administered or given by a specially-trained healthcare provider. Because of its longer duration of action, Idelvion may potentially require less frequent injections than unmodified Factor IX when used for prevention.
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3. Idelvion is used to replace Factor IX, a naturally occurring clotting factor that is missing or defective in people with hemophilia B, also known as Factor IX deficiency or Christmas disease. It is produced by recombinant DNA technology linking Factor IX to albumin, which allows the drug to last longer when given intravenously.
4. Idelvion is indicated in children and adults with hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control and prevention of bleeding episodes; and the perioperative management of bleeding (around the time of surgery).
5. FDA's approval of Idelvion is based on results of two multicenter studies, which included a total of 90 adult and pediatric patients with hemophilia B. Idelvion was shown to be effective in controlling bleeding episodes and in managing perioperative bleeding. When used as prophylaxis, the drug led to a significant reduction in the rate of spontaneous bleeding episodes per year despite less frequent infusions.
6. The most common adverse reaction associated with the use of Idelvion in the studies was headache.
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