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FDA Approves CSL Behring's Self-Administered C1 Esterase Inhibitor HAE Prophylactic

06:21 EDT 23 Jun 2017 | Genetic Engineering News

The FDA approved CSL Behring’s subcutaneously administered C1 esterase inhibitor (human), Haegarda, for routine use in preventing hereditary angioedema (HAE) attacks in adolescent and adult patients. The approval marks the first for a subcutaneously C1 esterase inhibitor which gives patients the option to self-inject at home. "The approval of Haegarda provides a new treatment option for adolescents and adults with hereditary angioedema," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "The subcutaneous formulation allows patients to administer the product at home to help prevent attacks." “The FDA approval of Haegarda is an important milestone for the HAE community because it addresses the primary need of patients: to effectively prevent debilitating HAE attacks,” added Andrew Cuthbertson, M.D., Ph.D., CSO and R&D director, CSL. FDA clearance of Haegarda was based on data from a clinical trial of 90 symptomatic HAE patients ...

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