FDA staff large­ly un­fazed by CV sig­nal in Am­gen os­teo­poro­sis drug tri­als

FDA staff braved the snow and the fed­er­al shut­down to post their re­view of Am­gen’s once-re­ject­ed os­teo­poro­sis drug on Mon­day, un­der­scor­ing that the ef­fi­ca­cy of the drug in post­menopausal women had been es­tab­lished, and sug­gest­ing that the CV sig­nal ob­served in two tri­als may not be a sig­nif­i­cant wor­ry.

The re­view comes days af­ter Am­gen and part­ner UCB se­cured Japan­ese ap­proval for the drug, ro­mosozum­ab, and pre­cedes a meet­ing of in­de­pen­dent ex­perts on Wednes­day who will make their rec­om­men­da­tion on the ap­prov­abil­i­ty of the drug in the Unit­ed States. Ro­mosozum­ab — which is to be sold un­der the brand name Eveni­ty — func­tions pre­dom­i­nant­ly as a bone an­a­bol­ic agent that stim­u­lates bone growth.

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