Re­gen­eron flash­es ‘great ad­vance' in the NE­JM for that oth­er cho­les­terol drug sit­ting at the FDA

When it comes to ex­per­i­men­tal cho­les­terol drugs, all eyes this year are on in­clisir­an, the $9.7 bil­lion RNAi drug No­var­tis hopes will re­place and vast­ly out­sell Re­gen­eron and Am­gen’s PC­SK9 in­hibitors.

Yet Re­gen­eron has been qui­et­ly prepar­ing for ap­proval of its own new cho­les­terol drug, a niche an­ti­body meant to treat a nar­row slice of pa­tients not cov­ered by Pralu­ent, the biotech’s orig­i­nal PC­SK9 in­hibitor. Last year, the com­pa­ny re­port­ed topline, piv­otal da­ta. Last week, a BLA sub­mis­sion for the drug, known as evinacum­ab, was ac­cept­ed and giv­en pri­or­i­ty re­view by the FDA.

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