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 The Food and Drug Administration said on Tuesday it approved the
drug, Bridion, to reverse the effects of deep paralysis caused by
rocuronium and vecuronium, muscle relaxants used at the beginning of
surgery to help doctors insert a breathing tube.
Analysts expect the drug, known generically as sugammadex, to
generate annual sales of $557 million by 2020 according to Thomson
Reuters data.
Bridion's path to approval has been rocky. The product was
originally developed by Organon BioSciences, which was acquired by
Schering-Plough in 2007. Merck acquired the drug when it bought
Schering-Plough in 2009.
In 2008 the FDA declined to approve it, citing concerns about
potential allergic reactions and bleeding. A 2013 advisory to
discuss the drug was abruptly canceled after the agency said it
needed more time to review the company's revised application.
In a statement announcing its approval, the FDA warned that
clinicians "should be aware of the possibility of a hypersensitivity
reaction or anaphylaxis and should intervene as appropriate."
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The agency also noted that cases of abnormally slow heart action, in
some cases resulting in cardiac arrest, have been reported within
minutes of administration of the drug and that patients should be
closely monitored.
(Reporting by Toni Clarke in Washington; Editing by James Dalgleish)
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