UK’s MHRA approves first drug under international recognition procedure
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.
The new formulation allows patients access to a “more convenient option compared to the current vial presentation, as denosumab will now be provided at the same dose but in a higher concentration, already loaded in a syringe. This simplifies the administration process, reduces the volume of liquid injected, and lowers the risk of dosing errors,” said MHRA.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) reviewed the product and issued a positive opinion on 25 January 2024. The MHRA accepted this assessment as part of its own review and approved the drug on 29 January.
MHRA said “IRP is open to applicants that have already received an authorisation for the same product from one of MHRA’s specified trusted regulators.” Those deemed trusted regulators include Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
“We are focused on providing UK patients rapid access to safe and effective medical treatments,” said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access. “I’m very pleased to announce that we have granted the first approval through IRP in 30 days, demonstrating that this new process for bringing new medicines to UK patients is well under way.”
The new international agreement leverages expertise from partners across the world, allowing treatments to be approved more quickly, according to UK’s Health Minister Andrew Stephenson.
MHRA
