UK relies on EMA’s review of Xgeva reformulation in first-ever reciprocal approval

For the first time since Brex­it, the UK’s med­i­cines reg­u­la­tor has made use of its new ap­proval path­way that can speed drug ap­provals based on the work of reg­u­la­tors in oth­er coun­tries.

In this case, the UK’s MHRA is re­ly­ing on the work of the Eu­ro­pean Med­i­cines Agency to sign off on a new for­mu­la­tion for Am­gen’s bone drug Xge­va (deno­sum­ab) in just 30 days. No new clin­i­cal tri­als were nec­es­sary for the for­mu­la­tion change.

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