Am­gen’s ex­pec­ta­tions for ro­mosozum­ab take a hit as Ra­dius lines up its ri­val os­teo­poro­sis drug

Am­gen has helped shore up ex­pec­ta­tions for its os­teo­poro­sis drug ro­mosozum­ab, re­leas­ing up­dat­ed Phase III da­ta that un­der­score its straight shot at a mar­ket­ing ap­proval. But the big biotech, which is part­nered on this pro­gram with UCB, may have to con­cede a big piece of this com­pet­i­tive mar­ket af­ter spelling out its fail­ure on a key sec­ondary end­point.

Ro­mo — which tar­gets the scle­rostin pro­tein — fol­lowed by Am­gen’s Pro­lia (deno­sum­ab) clear­ly vault­ed the bar in Phase III for re­duc­ing ver­te­bral frac­tures, with a hefty 75% risk re­duc­tion com­pared to a place­bo plus deno­sum­ab. In­ves­ti­ga­tors al­so were able to show a bet­ter safe­ty pro­file in its pre­sen­ta­tion at the an­nu­al con­fab of the Amer­i­can So­ci­ety for Bone Min­er­al Re­search. And there was an in­crease in bone min­er­al den­si­ty among the drug arm in the study, which re­cruit­ed 7,180 high-prism post­menopausal women.

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