The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international recognition procedure (IRP).
The IRP, which was launched on 2 January, aims to streamline the approval of new medicines that have been approved by other “trusted” regulators, yet the MHRA retains the ultimate approval authority. IRP replaces the EC Decision Reliance Procedure, according to an MHRA Notice. The new procedure stemmed from the UK’s withdrawal from the EU through Brexit.
Under the IRP, applications can be approved in 60-110 days, versus the current 150-day timeline.
The active ingredient in Xgeva is a protein that aims to delay bone destruction caused by cancer in adults and adolescents. The approval was for a line extension of the original marketing authorisation for Xgeva 120 mg solution for injection which was granted on 13 July 2011. The new formulation is a 120 mg solution for injection in a prefilled syringe for self-administration…
