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May 18, 2022

UK MHRA approves Roche’s faricimab for wet AMD and DMO

Faricimab is the first therapy to receive the UK MHRA approval through the Access Consortium initiative.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Roche’s faricimab (Vabysmo) for individuals with wet age-related macular degeneration (wet AMD) and impairment in vision due to diabetic macular oedema (DMO).

An eye injection, faricimab is a bispecific antibody intended to hinder two separate pathways associated with vision loss in wet AMD and DMO patients. 

The therapy is claimed to be effective in boosting vision or lowering vision loss in patients with these progressive eye diseases.

As against presently available therapies, faricimab can be administered less often in selected patients.

The regulatory agency noted that faricimab is the first therapy to obtain the UK MHRA approval through the Access Consortium ‘New Active Substance Work Sharing Initiative’.

The consortium is a partnership of regulatory agencies including of the United Kingdom, Singapore, Australia, Switzerland and Canada. 

It aims to expand global co-operation between partners, lower duplication and boost the capacity of each authority to guarantee timely access to safe and effective treatments for patients.

MHRA chief executive Dr June Raine, said: “We are pleased to work alongside other international regulators in the Access Consortium, which allows us to provide faster access to safe and effective medicines for all our populations, including those in the UK.

“Neovascular age-related macular degeneration and diabetic macular oedema are two leading causes of vision loss. 

“This approval highlights the significant benefit to patients in communication, collaboration and innovation with our international peers.”

The National Institute for Health Excellence (NICE) and Scottish Medicines Consortium (SMC) will provide advice on whether faricimab will be offered on the National Health Service (NHS).

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