Idelvion Approval History
- FDA approved: Yes (First approved March 4th, 2016)
- Brand name: Idelvion
- Generic name: coagulation factor IX (recombinant), albumin fusion protein
- Dosage form: Injection
- Company: CSL Behring
- Treatment for: Hemophilia B
Idelvion (coagulation factor IX (recombinant), albumin fusion protein) is a long-acting recombinant human blood coagulation factor indicated for the control and prevention of bleeding episodes in patients with hemophilia B.
Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX. Idelvion is recombinant coagulation factor IX with an extended half-life, developed through fusion with recombinant albumin for a longer duration of action. The approval of Idelvion is based on results of the PROLONG-9FP trial, which included data demonstrating high levels of factor factor IX activity in patients, at levels above 5 percent over 14 days.
Idelvion is administered via intravenous infusion with up to 14-day dosing in appropriate patients. The most common side effect reported during clinical trials was headache.
Development History and FDA Approval Process for Idelvion
|Mar 4, 2016||FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B|
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