Idelvion Approved for Hemophilia B
March 4, 2016 – The U.S. Food and Drug Administration announced its approval of CSL Behring’s Idelvion (Coagulation Factor 1X (Recombinant), Albumin Fusion Protein) to control and prevent bleeding episodes; to manage procedure-associated bleeding before, during and after surgery ; and to regularly prevent or reduce the frequency of bleeding episodes for Hemophilia B patients. Hemophilia B is a bleeding disorder affecting approximately 4,000 patients in the U.S., as a result of insufficient amounts of clotting Factor 1X, which is a protein in the blood that controls bleeding. Patients with the condition experience bleeding episodes that cause pain, irreversible joint damage, and life-threatening hemorrhages. The drug is given through intravenous (IV) infusion, with recommended doses, time between doses, and length of treatment, dependent on the indication, type, and extent of the bleeding and the patient’s body weight. To prevent bleeds, it is recommended that patients start use once every seven days, and based on how well the patient responds, the time between the infusions may eventually be as long as 14 days. Available dosage forms include single-dose vials containing 250 international units (IUs), 500 IUs, 1,000 IUs, or 2,000 IUs of powdered Idelvion. Each vial is packaged with the appropriate size vial of sterile water to reconstitute (mix with) the powder and the equipment necessary for reconstitution. CLS Behring plans to launch the drug at the end of the month, through a limited network of specialty pharmacies.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.