Sanofi hits the brakes on a top piv­otal pro­gram fol­low­ing 'new ad­verse events'

Ac­cord­ing to a trio of he­mo­phil­ia pa­tient groups, Sanofi has hit the brakes on a slate of late-stage stud­ies for fi­tusir­an, one of their Phase III pro­grams held up by CEO Paul Hud­son as a top prospect need­ed to help the turn­around he’s been push­ing hard at the phar­ma gi­ant. The drug has been linked to new cas­es of throm­bo­sis, which trig­gered an ear­li­er halt 3 years ago.

A state­ment from the World Fed­er­a­tion of He­mo­phil­ia, the Eu­ro­pean Haemophil­ia Con­sor­tium and the Na­tion­al He­mo­phil­ia Foun­da­tion notes that they had “con­firmed a de­ci­sion by Sanofi Gen­zyme to ini­ti­ate a vol­un­tary spon­sor-led glob­al dos­ing hold on its full clin­i­cal de­vel­op­ment pro­gram for fi­tusir­an due to the iden­ti­fi­ca­tion of new ad­verse events.”

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