Am­gen/UCB hit an­oth­er Eveni­ty hur­dle, as Eu­ro­pean reg­u­la­tors fail to back the os­teo­poro­sis drug

Am­gen $AMGN and its Bel­gian part­ners at UCB may have won over the FDA, but the EMA is still not con­vinced by their bone-build­ing os­teo­poro­sis drug ro­mosozum­ab.

On Fri­day, the com­pa­nies dis­closed that the Eu­ro­pean reg­u­la­tor had adopt­ed a neg­a­tive opin­ion on the drug, brand­ed Eveni­ty, for the treat­ment of os­teo­poro­sis in men and in post­menopausal women at in­creased risk of frac­ture. The part­ners plan to ap­peal the de­ci­sion.

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