Amgen secures first fast paced approval for life-saving new medicine

Amgen, based at ARC Uxbridge, has secured the first approval via the new International Recognition Procedure which aims to further help bring life-saving new medicines to UK patients without delay.

A new formulation for XGEVA (denosumab), a treatment used in adults to prevent serious bone-related complications caused by bone metastasis and to treat giant cell tumour of bone in adults and adolescents, is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, 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.

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:

“We are focused on providing UK patients rapid access to safe and effective medical treatments. 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. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”

Health Minister Andrew Stephenson said: “NHS patients should have access to the newest, most effective medicines and treatments without delay. This new international agreement allows treatments to be approved more quickly by drawing on expertise from partners across the world, reducing bureaucracy and sharing resources so patients can benefit as soon as possible. XGEVA being approved quicker than usual is testament to this innovative approach.”

You can read the full release here

ARC Uxbridge has a growing biotech and pharmaceutical cluster including join biotech and including, Bristol Myers Squibb, Parexel and Daiichi Sankyo.