UK MHRA approves Roche’s faricimab for wet AMD and DMO
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Roche’s Vabysmo (faricimab) for treatment of wet age-related macular degeneration and diabetic macular edema-related visual impairment.
The approval is the result of an international collaboration known as Access Consortium, which is designed to reduce duplication and align regulatory requirements across different regulatory agencies. The consortium’s members include the UK, Canada, Australia, Switzerland and Singapore.
The faricimab approval is the first MHRA granted under the collaborative program.
“We look forward to working together with international regulators on our shared goals of patient safety and access to new treatments,” said June Raine, MHRA’s chief executive.
May 20, 2022