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June 13th, 2005
Octagam Post- Marketing Surveillance data presented at FDA workshop
Clinicians, consumers, regulators, manufacturers and other stakeholders with an interest in immune globulin therapy, gathered at the National Institutes of Health (NIH), Bethesda, MA on 13th April for a workshop jointly organized by the Immune Deficiency Foundation (IDF) and the Food & Drug Administration (FDA).
The meeting, chaired by the FDA's Dr Dorothy Scott was entitled: Intravenous Immune Globulins in the 21st Century: Progress and Challenges in Efficacy, Safety, and Paths to Licensure
Key Note Speaker, Prof. Hans Ochs from the University of Washington opened the meeting with a: Perspective on the history of IGIV, current important problems and questions in the field
The remainder of the full-day workshop was divided into three sessions:
- IGIV Efficacy
- Topics in IGIV Safety
- IGIV Licensure for Treatment of Primary Immune Deficiency
The first of these sessions included a variety of presentations on the epidemiology and outcome of infections in PID patients and the levels of antibodies in commercial IGIV preparations. The second session examined adverse events and adverse event surveillance. Amongst these presentations, was one entitled: Prospective post-marketing surveillance of Octagam:10 year experience in Germany
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This lecture, given by by Octapharma USA's Medical Affairs Director, Judi Miller, provided a comprehensive overview of the ongoing Octagam pharmacovigilance study in Germany. The presentation addressed the rationale for performing the study, it's design results and interim conclusions.
For the majority of the audience, this was the first introduction to this data. Many expressed both suprise and admiration that Octapharma had voluntarily undertaken such ground-breaking active post-marketing surveillance.
Until now, most of the data on adverse events with IVIG has been derived from either small-scale licensure studies in homogenous patient populations or from passive periodic safety update reports.
Whilst such information is helpful in the understanding of the safety and tolerability of individual IVIG preparations, manufacturers are frequently criticised for the lack of head-to-head studies and the fact that the existing studies provide insufficient data on the use of IVIG in routine clinical practice to draw any meaningful conclusions on adverse events.
IThe audience was therefore extremely impressed by the scope and scale of the Octapharma / Octagam study. Data presented here, covered the 10 year continuous observation period from February 1995 - February 2005.
During this time, information on the tolerability of Octagam was prospectively documented in >6,000 patients who collectively received more than 90,000 infusions. In this period, total adverse events occurred in fewer than 0.4% of infusions. The majority of these were classified as either mild or moderate and appear to be related to symptoms of the underlying pathology i.e. chills and fever in patients with primary immune deficiency and headaches in patients with neurological illness or ITP.
Surprisingly, and contrary to "accepted wisdom" adverse events did not appear to be correlated to either total dose or the rate of Octagam infusion.
In concluding, Ms. Miller stated that although comparative data of different IVIG preparations are still lacking, this study clearly demonstrates the excellent tolerability of Octagam in routine clinical use.
A pdf copy of this presentation can be downloaded by clicking here
(Please note that clicking on this link will take you outside of the Octapharma web site)
 PDF files require the free Adobe Acrobat Reader.
The final session of the workshop looked at the current paradigm for intravenous and subcutaneous immune globulin licensure and the critical path for future IVIG studies.
For a full transcript of the meeting please click here
(Please note that clicking on this link will take you outside of the Octapharma web site)
© Octapharma AG, 2005 |
