PPTA Letter to Stakeholders re: European Data Program Update

Dear PPTA Stakeholders:

I would like to provide a status report on implementation of PPTA’s European Data Program.

As you know, PPTA launched the program in November 2013 starting with the reporting of Recombinant Factor VIII data. We committed as well to soon begin reporting data on a more complete set of plasma protein therapies. Today we are able to honor that commitment. Please click here to access the data.

As you can see, in addition to Recombinant Factor VIII, the enclosed charts include aggregate distribution data, on a country-by-country basis, for the following product categories:

  • Albumin ≤ 5%
  • Albumin 20% - 25%
  • Intravenous Immune Globulin
  • Subcutaneous & Intra-Muscular Immune Globulin
  • Plasma-Derived Factor VIII
  • Plasma-Derived Factor IX

At the time of our December 11 letter, PPTA also committed to meet with both patient advocacy groups and regulators to explain the Data Program’s operational details and benefits. Those outreach efforts continue to move forward as well. 

As far as next steps are concerned, while PPTA will continue with informational outreach to patient groups and regulators, the Data Program is now live. Although we will continue to seek user feedback and to make modifications as circumstances require, the initial implementation phase has come to an end.

If you have additional questions or would like to discuss further, please contact the Association at your convenience.

Santoni 2

Bruno Santoni
Executive Director, Europe

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