Med­i­cines Co., Al­ny­lam pre­pare to throw the dice on a late-stage ef­fort to leapfrog PC­SK9 gi­ants

While Am­gen and its ri­vals at Re­gen­eron/Sanofi strug­gle to es­tab­lish a mar­ket for their pi­o­neer­ing PC­SK9 ther­a­pies — while grap­pling over a nasty law­suit over the IP — Al­ny­lam $AL­NY and The Med­i­cines Com­pa­ny $MD­CO are hatch­ing plans for a come-from-be­hind at­tempt to leapfrog the squab­bling fron­trun­ners.

This morn­ing the com­pa­nies an­nounced that the FDA has signed off on their Phase III pro­gram, which will en­roll a to­tal of 3,000 sub­jects with ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease and fa­mil­ial hy­per­c­ho­les­terolemia to test the abil­i­ty of in­clisir­an to slash LDL over 18 months. And they aren’t wait­ing for the re­sults to be­gin their car­dio out­comes study.

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