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news.BTG has announced that Swissmedic, the Swiss Agency for Therapeutic Products, has approved the antidote, DigiFab, for the treatment of patients with life-threatening digitalis intoxication. DigiFab is already available in Switzerland under a conditional marketing authorisation and in other European countries under named patient programmes.
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BTG has a licensing agreement with Beacon Pharmaceuticals for the marketing of DigiFab in Europe, and Beacon has sub-licensed DigiFab distribution in Switzerland to Proreo Pharma.
DigiFab has been licensed by the FDA since 2001 and BTG is establishing commercial operations to market DigiFab in the US from 1st October 2010. DigiFab is currently under review by the MHRA, the UK regulator and by Health Canada, the Canadian regulatory authority. BTG plans to seek additional European approvals in due course via the mutual recognition procedure.
Digoxin, also known as digitalis, is a drug used to treat congestive heart failure and to slow heart rate in some cardiac disturbances. It has a narrow therapeutic window, meaning it is easy to move from therapeutic levels to toxic levels as a result of overdose, slow elimination or interaction with other drugs. DigiFab works by binding and neutralising digoxin, facilitating its redistribution away from target tissues and elimination from the body.
Louise Makin, CEO of BTG, said: “We are delighted to announce BTG’s first European approval for DigiFab. This comes as we continue to progress preparations to market both CroFab and DigiFab in the US from 1st October 2010.”