The PROFNAIT project is being conducted by 11 European hospitals, universities and businesses and aims to develop a prophylatic treatment of FNAIT.
The project is supported by the EU’s 7th Framework Programme (2012-2018).
The project aims to convert plasma donated by immunized women from the USA, Germany, Norway, Sweden and Holland into a new, safe medicine for the prevention of FNAIT. To do this, test medicine is first made from the collected plasma and used to document that it is safe and effective in preventing FNAIT in fetuses and newborns. Based on this documentation, the European Medicines Agency (EMA) will be asked to approve the new FNAIT medicine.
If you are from the above countries and know or suspect that you have antibodies to HPA-1a and would like to donate plasma for this project please click the following link for further information:
26 February 2016
Prophylix has with the continuous support of naitbabies.org members and our plasma collection partners in the US succeeded in collecting enough plasma for the first 2 batches of NAITgam. With these two batches we can complete the clinical development of NAITgam. A third batch will not be required until the full development program is completed and Prophylix is ready to apply for marketing authorizations with the regulatory authorities in Europe and North America.
Since plasma is a biological product with a limited shelf-life and because we do not need more plasma now, Prophylix has decided to put the collection of further plasma on hold. Prophylix is currently discussing the endpoints of last collections with our collaborate blood establishments and we will reach out to the donors with more specific information. We at Prophylix and our PROFNAIT partners highly appreciate the huge efforts that everybody involved has made to bring us a very important step closer to preventing FNAIT and a deep felt thank you goes to all of you donors and to naitbabies.org. We very much hope to see you all again when it is time to resume the plasma collection program. Naitbabies.org will notify all of its members when that happens.