No ear­ly suc­cess for Re­gen­eron, Sanofi in PhI­II out­comes study for PC­SK9 drug Pralu­ent

Christ­mas is not com­ing ear­ly for Re­gen­eron and Sanofi.

The com­pa­nies not­ed ear­ly to­day that they will have to go all the way to the end of their out­comes tri­al to see if their PC­SK9 drug Pralu­ent can de­liv­er the goods in re­duc­ing the risk of a ma­jor car­dio event af­ter fail­ing to find over­whelm­ing ev­i­dence of suc­cess in its sec­ond pre­lim­i­nary re­view of the tri­al.

In­ves­ti­ga­tors re­cruit­ed 18,000 pa­tients with un­con­trolled LDL for the big tri­al, which will need to be pos­i­tive if they ever ex­pect to open up the mar­ket for their cho­les­terol drug. Pay­ers have dug their heels in on this drug, along with the ri­val Repatha from Am­gen, which just de­liv­ered fresh bio­mark­er da­ta to in­di­cate the like­li­hood of bend­ing the curve on ef­fi­ca­cy for an at-risk group of pa­tients.

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