Highlights of EMA Pharmacovigilance unit meeting

At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on products that contain Factor VIII and discussed a fatality in a patient treated with Tecfidera.

The Committee has looked at new evidence from two recently published studies suggesting that previously untreated hemophilia patients may be at greater risk of developing inhibitors (antibodies) if treated with the Factor VIII medicines Kogenate Bayer, from German pharma major Bayer (BAYN: DE) and Helixate NexGen from CSL Behring, a unit of Australia's CSL Ltd (ASX: CSL), than if treated with other products that contain factor VIII (the blood clotting factor needed by hemophilia patients).

The development of inhibitors is a known risk with products that contain Factor VIII. In 2013 the PRAC reviewed the evidence available at the time about the development of inhibitors in these patients and found that it did not support an increased risk in those treated with Kogenate Bayer/Helixate NexGen. In the light of the new data, the PRAC is recommending a further in-depth examination of the available evidence.