Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016

News 13/05/2016

PRAC concludes on meta-analysis on the risk of inhibitor development in severe haemophilia patients receiving recombinant factor VIII products

The Pharmacovigilance Risk Assessment Committee (PRAC), at its May meeting, adopted a summary report following the review of a meta-analysis of data from three observational studies, aiming to assess the risk of developing inhibitors (antibodies) against individual recombinant factor VIII products in previously untreated patients with severe haemophilia A. Factor VIII is lacking in patients with haemophilia A and is given to these patients either to treat bleeding episodes on demand or regularly as prophylaxis to allow their blood to clot normally; the development of inhibitors can lead to a reduction of the therapeutic action of the medicine.

The PRAC agreed that overall, the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in previously untreated patients. These conclusions are consistent with the previous conclusions drawn by the PRAC within the review carried out on Kogenate Bayer/Helixate NexGen in 2013.

The PRAC recommended that the marketing-authorisation holders of recombinant factor VIII products should monitor published studies on drug inhibitor development with the aim of keeping the product information up-to-date.

This meta-analysis was made possible through close collaboration with academia. The investigators of the studies provided anonymised raw data for a rigorous analysis led by the PRAC rapporteur, enabling an additional independent evaluation to further assess the safety profile of these medicines.

More information on the results of this meta-analysis is provided in a PDF icon summary document .

Ongoing referrals

During its May meeting, the PRAC discussed one ongoing safety review. More information on all ongoing referrals is included in the table below. The PRAC did not initiate or conclude a safety referral this month.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting, held from 6-9 June.


PDF icon Agenda - PRAC draft agenda of meeting 10-13 May 2016

Ongoing referrals

Article-20 procedure: CanagliflozinUnder evaluationPRAC continued its assessment
Article-20 referral: Direct-acting antivirals for treatment of hepatitis C (interferon-free)Under evaluationPRAC continued its assessment
Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationPRAC continued its assessment
Article-20 referral: ZydeligUnder evaluationPRAC adopted a list of experts for the Scientific Advisory Group (SAG) meeting, and continued its assessment.

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