Highlights of the PRAC monthly meeting held in May published

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) had released a summary of the topics discussed at its latest meeting held on 2nd to 5th May 2017.

These included completion of its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with haemophilia A who have not previously been treated with these medicines.

The review was instigated following publication of a study which concluded that inhibitors develop more frequently in patients receiving recombinant factor VIII medicines than in those receiving plasma-derived factor VIII medicines. The hypothesis was that the inhibitors can block the effect of these medicines, so bleeding is no longer controlled. However, the PRAC concluded that there is no clear and consistent evidence of a difference in inhibitor development between the two classes of factor VIII medicines.

Following an Article 31 referral on Gadolinium-containing contrast agents, PRAC issued a recommendation March 2017.  Some marketing authorisation holders asked for a re-examination which is expected to conclude in July 2017.

To read the summary and associated meeting documents, please click here.