European Union - The Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has recommended intensive post-marketing surveillance for all new patients treated with nonacog alfa, human recombinant factor IX (BeneFIX®), as well as the initiation of two new clinical trials. The recommendations have been made following a good clinical practice (GCP) inspection of two of the three pivotal clinical studies on which the marketing authorization is based.

Nonacog alfa has been commercially available in the United States since 1997 and in Europe since 1999. Post-marketing data since then support the safety and efficacy profile of the product. The CPMP considers that the benefit/risk balance of nonacog alfa for the treatment and prophylaxis of bleeding in previously treated patients with haemophilia B is positive, based on the data presently available. However, these are insufficient to be certain of the frequency of some adverse drug reactions, especially those linked to inhibitor formation and to allergic reactions.

Patients treated with nonacog alfa may continue their therapy. However, patients who experience suspected adverse reactions should be monitored carefully and the risk/benefit of continued treatment should be evaluated. In the case of severe allergic reactions, alternative haemostatic measures should be considered. To date, there are insufficient data to recommend the use of nonacog alfa in children less than 6 years of age and to provide information on inhibitor incidence in previously untreated patients.

Reference: EMEA Public Statement on BeneFIX, 4 October 2001, http://www.emea.eu.int