Track topics on Twitter Track topics that are important to you
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. 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 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 Dr. Andrew Cuthbertson, CSO and R&D director, CSL Limited. FDA clearance of Haegarda was based on data from a clinical trial in 90 symptomatic HAE patients aged from ...NEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...