Shire plc presents at ASH 40 years of real-world experience with the bypassing agent FEIBA [Anti-Inhibitor Coagulant Complex], a treatment for Hemophilia A.

Shire plc will present an update on its safety database describing 40 years of real-world experience with the bypassing agent FEIBA [Anti-Inhibitor Coagulant Complex]. Shire also revealed new in vitro data showing the potential for excessive thrombin generation when combining an investigational procoagulant bispecific antibody and bypass therapy for breakthrough bleeds. These data are now available online as part of the Proceedings of the 58th American Society of Hematology (ASH) Annual Meeting, to be held December 3-6 in San Diego, California.

Inhibitors are a rare but serious complication impacting about 5-7 percent of patients with hemophilia A. They form when the body�s immune system attacks the molecules in factor therapy, causing it to be ineffective. Bypassing agents help bypass the inhibitor to help the body form a clot and stop bleeding. Recently, concerns have emerged related to the use of an investigational non-factor product when combined with marketed bypassing agents for hemophilia patients with inhibitors. Shire conducted an analysis of a sequence analogue biosimilar of one investigational agent, emicizumab, in combination with bypassing agents. Researchers characterized in vitro the rate and level of thrombin generation resulting from combining the bypassing agent and investigational non-factor product. The data found a multi-fold increase in thrombin generation, indicating a potential thrombotic risk for patients who receive the investigational agent combined with an approved bypass agent for breakthrough bleeds. (Synergistic Effects of a Procoagulant Bispecific Antibody and Rescue Therapies on Thrombin Generation- a Potential Safety Risk, http://www.bloodjournal.org/content/128/22/4952.)

The risk of thromboembolic events (TEEs) is well characterized in the FEIBA label. FEIBA has a boxed warning for identified thromboembolic risk. Approximately three TEEs have been reported per 100,000 infusions based upon more than seven billion units (equivalent to about two million infusions) distributed over the past 40 years.

During ASH, Shire is presenting an update on its safety database describing the real-world experience with FEIBA. The global review of safety databases for AE reports of FEIBA received from 1975 through July 2016 showing the reporting rate of TEEs associated with FEIBA is comparable with previously reported data.