Ixinity Approved for Hemophilia B
April 30, 2015 – The U.S. Food and Drug Administration (FDA) approved Ixinity [coagulation factor IX (recombinant)], manufactured by Emergent BioSolutions. Ixinity is indicated for the control and prevention of bleeding episodes and for perioperative management in adults and children 12 years of age and older with Hemophilia B.
Hemophilia B is a bleeding disorder affecting approximately 4,000 patients in the United States which is caused from insufficient amounts of clotting Factor IX, a protein in the blood that controls bleeding. Patients with hemophilia B experience bleeding episodes that cause pain, irreversible joint damage and life-threatening hemorrhages.
Ixinity is a lyophilized powder in single-use glass vials containing 500, 1000 or 1500 international units (IU) per vial for intravenous use after reconstitution. Emergent BioSolutions plans on launching Ixinity within two months through a limited network of specialty pharmacies. Pricing information is not yet available.
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.