PROFNAIT

PROFNAIT project

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The PROFNAIT project aims to convert plasma from immunized women in the United States, Germany, Norway and Sweden (left) to a new, safe medicine for prevention of FNAIT (right). 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.

The project is rather complex. Hundreds of liters of plasma is required to make the test medicine. Thereafter, around 80,000 pregnant women are tested to identify 1,600 women who are HPA-1a negative and at risk of being HPA-1a-immunized. These women will be given either test medicine or placebo within hours after they have given birth. The studies will show if the test medicine is safe and effective in preventing immunization of the HPA-1a negative women.