Sec­ond time's a charm for os­teo­poro­sis drug from Am­gen, UCB as FDA pan­el grants its bless­ing

Looks like Am­gen and UCB’s os­teo­poro­sis drug is head­ed to the fin­ish line, af­ter an FDA pan­el large­ly sup­port­ed its ap­proval on Wednes­day. But if ap­proved, it will like­ly car­ry a black box warn­ing ad­vis­ing against its use in pa­tients with high car­dio­vas­cu­lar risk.

The rec­om­men­da­tion fol­lows a rosy re­view from FDA staff post­ed on Mon­day, who un­der­scored ro­mosozum­ab’s ef­fi­ca­cy in post­menopausal women with a high risk of frac­ture had been es­tab­lished, and sug­gest­ed that the CV sig­nal ob­served in some tri­als may not be a sig­nif­i­cant wor­ry. An in­de­pen­dent pan­el of ex­perts whose rec­om­men­da­tions the FDA typ­i­cal­ly fol­lows en­dorsed the drug, in light of its ef­fi­ca­cy in pa­tients that usu­al­ly have few treat­ment op­tions, but sug­gest­ed the CV risk be char­ac­ter­ized post ap­proval.

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