Important KALBITOR Safety InformationAnaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. KALBITOR should not be administered to patients with known clinical hypersensitivity to KALBITOR.
As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program. The goal of the REMS is to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.
For more information about KALBITOR, including full prescribing information, visit www.KALBITOR.com .
About DyaxDyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company's key value drivers are the KALBITOR \ business, DX-2930 and the Licensing and Funded Research Program (LFRP). Dyax developed KALBITOR on its own and, since February 2010, has been selling it in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older. Outside the United States, the Company has established partnerships to obtain regulatory approval and commercialize KALBITOR in certain markets and is evaluating opportunities in others. The Company is developing products to expand its angioedema portfolio, including a therapeutic candidate, DX-2930, for the prophylactic treatment of HAE and a biomarker assay to identify plasma- kallikrein-mediated disorders. In August 2013, Dyax began a Phase 1 clinical study evaluating the safety and tolerability of single subcutaneous administration of DX-2930 in healthy subjects. KALBITOR and DX-2930 were identified using Dyax's patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the LFRP. This program has provided the Company a portfolio of product candidates being developed by its licensees, which currently includes 13 revenue eligible product candidates in various stages of clinical development, including three in Phase 3 trials.
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