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Sunday, June 07, 2015

FDA Approves a New Factor IX Treatment for Hemophilia B!


The following is a paid public awareness notice from Emergent BioSolutions about a recently approved FIX treatment.

Earlier this year I spotlighted the Emergent-sponsored mentorship program for teens and adults with hemophilia B (Calling All B’s—Be Part of the Generation IX Project! Or, way back in May 2014, when I shared my admiration for John Taylor, co-founder of the Coalition for Hemophilia B, and his work with Emergent BioSolutions to help bring a new factor IX to market (A Promising Future with Hemophilia B). 

 Well, our era of expanding treatment choices for hemophilia continues with the FDA-approval of Emergent’s IXINITY® [Coagulation Factor IX (Recombinant)] for people with hemophilia B. Now there's more than one recombinant factor IX for hemophilia B people to rely on. 

More choice means more product differences to consider. That means it’s now more  important than ever to educate ourselves and understand differences among treatments. It also puts more power in the hands of patients to select a treatment that fits their needs and their lifestyles. 

Another great thing about the expansion of treatment choice is that it stresses how important it is for manufacturers to create a more positive treatment experience by offering additional programs that help individual people and the whole hemophilia B community.

More information about IXINITY is below. You can visit the site at IXINITY.com for more on what they call the IXINITY IXperience™. 


 With IXINITY, you define the IXperience. 
Predictable bleed control for your active, unpredictable life. 

• 98% average incremental recovery.Higher recovery may allow lower doses.1* 

• Third-generation† factor IX with no inhibitors developed in a clinical study.1‡ 
• 24-hour half-life for peak factor levels when you need them.


Start your FREE trial. Call 1-855-IXINITY (1-855-494-6489) to talk with your IXperience Concierge™. 
    • With your FREE trial of IXINITY, you’ll receive 1 month of free treatment up to 20,000 IU. 
    • After that, if you’re covered by commercial insurance, you may continue to   
    pay nothing out-of-pocket for IXINITY regardless of income. 

The IXINITY Savings Program: You can save up to $12,000 annually.§ 
    • NO income requirements 

    • NO out-of-pocket costs∥ 

    • NO monthly limits 

If you have commercial health insurance, you can save up to $12,000 a year for treatment with no income requirements or caps and no monthly limit over the $12,000 annual maximum. 



*The pharmacokinetics of IXINITY have been evaluated in 32 previously treated patients ≥12 years of age with severe to moderately severe hemophilia B.
†Third-generation product is defined by the National Hemophilia Foundation Medical and Scientific Advisory Council as recombinant factor IX (rFIX) produced in Chinese hamster ovary cells; no human or animal plasma-derived proteins are used in the manufacturing process2
The efficacy (n=68) and safety (n=77) of IXINITY has been evaluated in a prospective, open-label, uncontrolled, multicenter trial in which previously treated patients (PTPs) between 7 and 64 years of age received IXINITY in either a routine or on-demand regimen.
§Program does not cover government healthcare costs (Medicare, Medicaid, and TRICARE) or costs associated with therapy administration. Other restrictions may apply, and a US prescriber and pharmacy are required. Emergent BioSolutions reserves the right to rescind, revoke, or amend this offer without notice. 
May depend on your individual health insurance. 

IXINITY INDICATIONS AND IMPORTANT SAFETY INFORMATION 
What is IXINITY®? 
IXINITY [coagulation factor IX (recombinant)] is a medicine used to replace clotting factor (factor IX) that is missing in adults and children at least 12 years of age with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare provider may give you IXINITY to control and prevent bleeding episodes or when you have surgery. 
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. 

IMPORTANT SAFETY INFORMATION FOR IXINITY® 
 You should not use IXINITY if you are allergic to hamsters or any ingredients in IXINITY. 
 You should tell your healthcare provider if you have or have had medical problems, take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies, have any allergies, including allergies to hamsters, are nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX. 
 You can experience an allergic reaction to IXINITY. Contact your healthcare provider or get emergency treatment right away if you develop a rash or hives, itching, tightness of the throat, chest pain, or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting. 
 Your body may form inhibitors to IXINITY. An inhibitor is part of the body’s defense system. If you develop inhibitors, it may prevent IXINITY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to IXINITY. 
 If you have risk factors for developing blood clots, the use of IXINITY may increase the risk of abnormal blood clots. 
 Call your healthcare provider right away about any side effects that bother you or do not go away, or if your bleeding does not stop after taking IXINITY. 
 The most common side effect that was reported with IXINITY during clinical trials was headache. 
 These are not all the side effects possible with IXINITY. You can ask your healthcare provider for information that is written for healthcare professionals. 


Please see full Prescribing Information for IXINITY. 





You are encouraged to report side effects of prescription drugs to the Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 

References: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Winnipeg, MB, Canada; Emergent BioSolutions Inc.; April 2015. 2. National Hemophilia Foundation Medical and Scientific Advisory Council (MASAC). MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. MASAC Document #230. September 2014. 

Manufactured by Cangene Corporation, a subsidiary of Emergent BioSolutions Inc. and distributed by Cangene bioPharma, Inc., a subsidiary of Emergent BioSolutions Inc. 

IXINITY® [Coagulation Factor IX (Recombinant)] and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos, slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved. 
©2015 Emergent BioSolutions Inc. 








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