Idelvion FDA Approval History
FDA Approved: Yes (First approved March 4, 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 timeline for Idelvion
| Date | Article |
|---|---|
| Mar 4, 2016 | Approval FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B |
Further information
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