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NICE recommends Novartis’ Beovu for wet age-related macular degeneration

pharmafile | December 16, 2020 | News story | Research and Development NICE, Novartis, wet AMD Beovu 

NICE has published its final appraisal of Novartis’ Beovu (brolucizumab), recommending that the drug be made available via the NHS in England and Wales for the treatment of wet age-related macular degeneration in adults.

Wet AMD is characterised by degenerating vision as a result of leakage of blood and fluid at the back of the eye. Beovu suppresses the growth of faulty blood vessels and reduces the potential for leakage. Macular disease, of which wet AMD is a part, is the leading cause of sight loss in the UK, something which costs the national economy up to £25.2 billion a year.

The watchdog based its decision on Phase III clinical data from two studies which demonstrated that Beovu proved non-inferior to Regeneron’s Eylea (aflibercept) in generating improvements in best-corrected visual acuity (BCVA) from baseline 48 weeks following initial dosing – around 30% of Beovu patients gained at least 15 letters in that time from as early as four weeks following first dose.

Additionally, in one of the studies, 31% of Beovu patients presented intra-retinal and/or sub-retinal fluid compared to 45% of Eylea patients after 48 weeks of treatment.

“Wet AMD can progress rapidly and cause significant visual loss in as little as three months. Wet AMD can be managed with effective, consistent treatment and regular monitoring of fluid in the back of the eye,” explained Robin Hamilton, and UK Chief Investigator for the HARRIER study. “Consultant Ophthalmic Surgeon at Moorfields Eye Hospital. “Results from HAWK and HARRIER clinical studies showed that brolucizumab offers greater retinal fluid resolution versus the comparator. Today’s recommendation offers patients access to a treatment option that has the potential to minimise the treatment burden and hospital visits, while improving their vision and slowing down the progression of their wet AMD. This should give them more time to do the things that matter most to them.”

Matt Fellows

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