Es­pe­ri­on’s cho­les­terol drug clears the last big safe­ty hur­dle, turn­ing the cor­ner to the FDA — now the big chal­lenge looms

Es­pe­ri­on $ES­PR looks set to make the fi­nal step in its long jour­ney to­ward a mar­ket­ing ap­pli­ca­tion at the FDA, with good odds of suc­cess next year. But the lat­est batch of pos­i­tive safe­ty and ef­fi­ca­cy da­ta won’t dis­pel the per­sis­tent ques­tions over its sales strat­e­gy.

That’s go­ing to take some hard dol­lar num­bers.

First, the tri­al da­ta.

The drug arm saw a mod­er­ate drop in LDL of 18% with a 19% cut in high-sen­si­tiv­i­ty C-re­ac­tive pro­tein. That fits in well with what we’ve seen be­fore in a string of Es­pe­ri­on stud­ies, with the ther­a­py fit­ting neat­ly be­tween the gener­ics that dom­i­nate the mar­ket and the PC­SK9s that have had trou­ble find­ing trac­tion, spurring some deep dis­count­ing that could spell trou­ble for Es­pe­ri­on.

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