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


The UK Medicines and Health Products Regulatory Agency (MHRA) has granted approval for Roche’s faricimab (Vabysmo) for people with wet age-related macular degeneration (wet AMD) and dementia. vision due to diabetic macular edema (DME).

An ocular injection, faricimab is a bispecific antibody intended to impede two distinct pathways associated with vision loss in patients with wet AMD and BMD.

The therapy is believed to be effective in improving vision or reducing vision loss in patients with these progressive eye diseases.

Unlike currently available therapies, faricimab may be given less often in some patients.

The regulatory agency noted that faricimab is the first treatment to gain UK MHRA approval through the Access Consortium’s New Active Substances Worksharing initiative.

The consortium is a partnership of regulators including the UK, Singapore, Australia, Switzerland and Canada.

It aims to expand global cooperation between partners, reduce duplication and strengthen the capacity of each authority to ensure rapid access to safe and effective treatments for patients.

MHRA Chief Executive Dr June Raine said: “We are delighted to be working alongside other international regulators in the Access Consortium, enabling us to provide faster access to safe medicines. and effective to all our populations, including those of the United Kingdom.

“Neovascular age-related macular degeneration and diabetic macular edema are the two main causes of vision loss.

“This approval highlights the significant benefits for patients in communicating, collaborating and innovating with our international peers.”

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

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