Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hud­son’s top picks in the pipeline — picked up in a $3.7 bil­lion buy­out 2 years ago — has just been side­lined in the US by a safe­ty is­sue.

The phar­ma gi­ant put out word ear­ly Thurs­day that the FDA has put their Phase III stud­ies of tole­bru­ti­nib in mul­ti­ple scle­ro­sis and myas­the­nia gravis on par­tial clin­i­cal hold, halt­ing en­roll­ment and sus­pend­ing dos­ing for pa­tients who have been on the drug for less than 60 days. Pa­tients who have com­plet­ed at least 60 days of treat­ment can con­tin­ue ther­a­py as re­searchers ex­plore a “lim­it­ed” — but un­spec­i­fied in Sanofi’s state­ment — num­ber of cas­es of liv­er in­jury.

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