MedicalResearch.com Interview with:
Jerry Powell MD
North America Commercial Operations
MedicalResearch.com: What is the background for this study?
Response: The new IDELVION results presented at the American Society of Hematology (ASH) are from a pooled analysis of clinical studies from the global PROLONG-9FP clinical development program. The analysis assessed the relationship between estimated factor IX activity levels and clinical bleeding risk in adult hemophilia B patients treated with IDELVION using prophylaxis or on-demand (episodic) treatment.
The PROLONG-9FP clinical development program included five Phase I through Phase III open-label, multicenter studies evaluating the pharmacokinetics, safety and efficacy of IDELVION in children and adults with hemophilia B.
MedicalResearch.com: What are the main findings?
Response: The key results presented at ASH 2016 suggest that there is a statistically significant relationship between factor IX exposure and bleeding risk, as measured by the time from the start of treatment to the first major bleeding event.
These findings also provide a clinical rationale for targeting and maintaining factor IX trough activity levels above 5 or 10 percent to optimize treatment outcomes, aligning with World Federation of Hemophilia clinical guidelines for the management of hemophilia. Furthermore, IDELVION has been shown to maintain high mean steady-state factor IX levels (21 percent at 7 days and 13 percent at 14 days, on 7- and 14-day dosing regimens, respectively).
MedicalResearch.com: What should readers take away from your report?
Response: The data presented at ASH 2016 for IDELVION are exciting as they support the high factor IX levels and efficacy of IDELVION in reducing bleeding risk in adult hemophilia B patients. IDELVION is the only available recombinant factor IX therapy that maintains high factor levels using 14-day dosing intervals, helping to provide excellent bleeding control for hemophilia B patients. Additionally, IDELVION has been shown to maintain high mean steady-state factor IX levels (21 percent at 7 days and 13 percent at 14 days, on 7- and 14-day dosing regimens, respectively).
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We continue to investigate treatment advancements that have the potential to improve the lives of patients with serious medical conditions.
MedicalResearch.com: Is there anything else you would like to add?
Response: The IDELVION data presented at ASH reinforces CSL Behring’s promise to advance coagulation science and optimize treatment outcomes for people living with hemophilia. We believe that, by prolonging increased factor levels and reducing the treatment burden associated with frequent prophylactic dosing, IDELVION will continue to have a positive impact on patients with hemophilia B. CSL Behring has a broad portfolio of coagulation products and is constantly looking for novel approaches to improve the care of patients around the world.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Disclosure: Study supported by CSL Behring
Citation: ASH 2016
Bleeding Risk Reduction in Relation to Predicted Factor IX Levels in Hemophilia B Patients Receiving Idelvion (rIX-FP)
Disorders of Coagulation or Fibrinolysis
Program: Oral and Poster Abstracts
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I
Saturday, December 3, 2016, 5:30 PM-7:30 PM
Hall GH (San Diego Convention Center)
John Roberts, PhD et al
CSL Behring, King of Prussia, PA
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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