The safety and efficacy of Berinert for prophylactic therapy has not been established. Berinert is now available through specialty pharmacies and distributors in the US.
Robert Lefebvre, vice president and general manager of US commercial operations at CSL Behring, said: “The Berinert Expert Network is an excellent example of CSL Behring’s commitment to going ‘above and beyond’ for patients and healthcare professionals by offering innovative products and high-quality support programs designed to meet their needs.
“B.E.N. will ensure that individuals in the HAE community, including healthcare providers, patients and their caregivers, have access to Berinert and will have a single point-of-contact to assist with helping them to manage their medical condition.”
In clinical trials, the median time to onset of relief with Berinert was 48 minutes as compared to more than four hours with placebo. As claimed, B.E.N helps patients connect with medical experts who can provide information about their condition, and details on Berinert.
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In addition, through B.E.N., HAE patients will be able to connect with other patients via the US Hereditary Angioedema Association (HAEA). In this way, patients can benefit from additional valuable programs and resources designed for and by people with HAE.
The approval of Berinert was based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (IMPACT), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.
