FDA Approves Drugs for HAE Treatment

The Food and Drug Administration (FDA) has approved two new drugs for the treatment of acute attacks of hereditary angioedema (HAE), a rare genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway.

The first treatment, Berinert C1- Esterase Inhibitor by CSL Behring, was approved last October. The approval of Berinert was based on the results of the Phase II/III double-blind placebocontrolled International Multi-center Prospective Angioedema C1-Inhibitor Trial(IMPACT),which studied the efficacy and safety of C1-inhibitor concentrate.

The second treatment, Kalbitor by Dyax, was approved last December for patients 16 years of age and older. Kalbitor is a potent, selective and reversible plasma kallikrein inhibitor and the first subcutaneous HAE treatment approved in the U.S. As part of the approval, Dyax, together with the FDA, established a risk evaluation and mitigation strategy program to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.

In January, CSL Behring launched its Berinert Expert Network (BEN), a fullservice support program for healthcare providers and for HAE patients and their caregivers. BEN provides information and assistance in securing access to Berinert, insurance and reimbursement, educational resources and tools, and assurance and assistance. For more information about BEN, call (877) 236-4423.