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news.Knight Therapeutics, a leading Canadian specialty pharmaceutical company, and LFB, a biopharmaceutical Group focused on innovative therapeutics for serious and rare diseases, today announced that Knight's New Drug Submission (NDS) has been accepted for review by Health Canada for ATryn [Antithrombin (Recombinant)] for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
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"ATryn, an innovative treatment for patients with hereditary antithrombin deficiency, marks Knight’s first submission to Health Canada", said Jonathan Ross Goodman, President and CEO of Knight.
"ATryn is approved for sale in both the US and Europe and touches the lives of patients with hereditary antithrombin deficiency. We look forward to bringing this important treatment option to Canadian patients".
"This is another important milestone for ATryn. We look forward to working with Knight and Health Canada to ensure ATryn will become available to Canadian patients", said Christian Béchon, Chairman and Chief Executive Officer, LFB S.A.
Knight received the rights to commercialize ATryn in Canada through its acquisition of Orphan Canada’s assets in September 2014.
ATryn is a recombinant human antithrombin. If approved, ATryn would be used for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
ATryn, is the first and only recombinant antithrombin concentrate. ATryn received EMA approval in 2006 and FDA approval in 2009, for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.