BioCentury on BioBusiness,
Regulation
Shire, FDA disagree on reasons for withdrawal of Replagal BLA for Fabry's
Pointing fingers
By Steve Usdin
Washington Editor
Published on
Monday, March 26, 2012
Explanations for Shire plc's
decision to withdraw its BLA for Replagal agalsidase alfa two weeks ahead of an
advisory committee meeting boil down to a classic "he said, she said"
controversy, with the company and FDA pointing fingers at each other - and
Fabry's disease patients caught in the middle.
Shire says it withdrew the BLA
because briefing documents prepared for the planned March 27 meeting of FDA's
Cardiovascular and Renal Drugs Advisory Committee made clear the agency's
approval of the Replagal BLA would be contingent on the company running
additional pre-market trials.
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