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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

Mar  4, 2016Approval FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B

Further information

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