(RxWiki News) Patients with hemophilia B, a rare, inherited bleeding disorder, may soon have another treatment option.
That option is Idelvion, a coagulation factor-albumin fusion protein injection. The US Food and Drug Administration (FDA) approved Idelvion last Friday to treat adults and children with hemophilia B.
Idelvion is the first drug of its kind, according to the FDA. It is thought to last longer than other hemophilia B treatments in patients' blood.
Patients with hemophilia B are deficient in Factor IX, a substance in the blood that helps it clot. Without Factor IX, patients can experience repeated, severe bleeding episodes. Hemophilia B primarily affects men, but it can also affect women.
“The approval of Idelvion provides another important therapeutic option for children and adults with hemophilia B to help prevent or control bleeding and reduce the frequency of bleeding episodes,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
Researchers assessed Idelvion's safety and effectiveness in two studies that looked at 90 total patients — between the ages of 1 and 61 — with hemophilia B. The drug, which is manufactured by CSL Behring, appeared to reduce the overall number of bleeding episodes these patients experienced.
These studies uncovered no safety concerns tied to Idelvion, according to the FDA. Headaches were the most commonly reported side effect.
Idelvion works by replacing Factor IX, according to the FDA. The FDA approval of this drug for hemophilia B patients indicates it for control of bleeding episodes, routine use to help prevent episodes and for management of bleeding after surgery.