Am­gen, UCB are back pitch­ing once-re­ject­ed os­teo­poro­sis drug ro­mo to the FDA — but big hur­dles lie ahead

Ro­mosozum­ab is back.

Al­most ex­act­ly a year af­ter Am­gen $AMGN and its part­ners at UCB were hand­ed a re­jec­tion on the os­teo­poro­sis drug, they’ve repack­aged their ap­pli­ca­tion ac­cord­ing to the agency specs and will now take an­oth­er run at an ap­proval.

Once con­sid­ered a po­ten­tial block­buster, ex­pec­ta­tions for the ther­a­py have been dwin­dling since Ra­dius $RDUS beat them to the mar­ket with the ri­val Tym­los. Then they pub­lished late-stage da­ta un­der­scor­ing an im­bal­ance in car­dio risk that put the drug — which they want to mar­ket as Eveni­ty — un­der a cloud. 

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