New antibody drug formulation wins novel MHRA approval

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the first product via its new International Recognition Procedure (IRP). The approval was for a new formulation for XGEVA (denosumab), to prevent serious bone-related complications caused by bone metastasis in adults and to treat giant cell tumour of bone in adults and adolescents.

MHRA’s International Recognition Procedure

Significance of the inaugural approval

As a result of the international recognition, Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, highlighted that the new formulation of denosumab was authorised through the IRP in 30 days.

Launched in January 2024, the IRP enables the MHRA to accelerate the assessment of new medicines and thus allow patients in the UK to access treatments earlier.

The new International Recognition Procedure draws on expertise from partners around the world, UK’s Health Minister Andrew Stephenson shared.

MHRA stated: “medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies.”

New recognition routes to fast-track UK medicine access

MHRA noted that under the International Recognition Procedure agreement, time horizons for authorisations are set at 60 to 110 days. This is “considerably shorter” than the current 150-day time horizon for applications.

Denosumab was authorised via the IRP on 29 February 2024 as a 120mg solution for injection in a prefilled syringe. It will now be given to patients at the same dose but in a higher concentration. This simplifies administration and makes it more convenient. Overall, it reduces the volume of liquid injected and reduces the risk of dosing errors, MHRA explained.

Prior approval review of XGEVA (denosumab)

This formulation of XGEVA (denosumab) was reviewed by the European Medicines Agency (EMA) and received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 25 January 2024. The earlier decisions made by the EMA and CHMP were consolidated into the MHRA’s own review of the treatment, thus enabling a rapid approval process via the International Recognition Procedure.

MHRA confirmed that this new marketing authorisation was granted to Amgen Limited, as a line extension of the original marketing authorisation for XGEVA 120mg solution for injection, which was granted on 13 July 2011.