As Pralu­ent Q1 sales miss Wall Street ex­pec­ta­tions, FDA ex­pands drug's la­bel to re­flect CV risk re­duc­tion

Months af­ter spar­ring ri­vals Am­gen $AMGN and part­ners Re­gen­eron $REGN and Sanofi $SNY slashed the prices of their re­spec­tive PC­SK9 in­hibitors by 60% to $5,850 in a bid to im­prove tepid sales of the cho­les­terol drugs, the lat­ter has se­cured an ad­di­tion­al la­bel that sup­ports their prod­uct’s abil­i­ty to re­duce se­ri­ous car­dio­vas­cu­lar events.

Re­gen­eron/Sanofi’s Pralu­ent and Am­gen’s Repatha were orig­i­nal­ly ap­proved in 2015 amidst much fan­fare, and were pegged to at­tain block­buster sta­tus for their abil­i­ty to dra­mat­i­cal­ly low­er lev­els of LDL cho­les­terol, but in­stead faced push­back from in­sur­ers for their high stick­er prices ($14,000) that led to low­er-than-ex­pect­ed adop­tion, de­spite lat­er tri­als that demon­strat­ed the PC­SK9 in­hibitors al­so sig­nif­i­cant­ly cut the risk of heart at­tacks and strokes.

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