UK regulator approves first 'Access Consortium' treatment

A new medicine for eye diseases, which has come through the Access Consortium ‘New Active Substance Work Sharing Initiative', has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

The treatment is Faricimab, a new medicine for people with the progressive eye diseases wet age-related macular degeneration (wet AMD) and visual impairment due to diabetic macular oedema (DMO).

The Access Consortium ‘New Active Substance Work Sharing Initiative’ is a collaboration of regulatory authorities including the United Kingdom, Australia, Canada, Singapore, and Switzerland. The consortium’s goal is to maximise international co-operation between partners, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products. The MHRA joined the Consortium in October 2020.

Faricimab (Vabysmo), an eye injection made by Roche Products Limited, is a bispecific antibody designed to block two different pathways implicated in causing vision loss in patients with wet AMD and DMO. The treatment has been shown to be effective in improving vision or reducing vision loss in these patient groups but has the added benefit in that it can be given less frequently in selected patients than other medicines currently available.

Dr June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency 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. We look forward to working together with international regulators on our shared goals of patient safety and access to new treatments."

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