NICE recommends Novartis’ wet AMD drug Beovu

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ anti-VEGF treatment Beovu (brolucizumab) for routine NHS use in wet age-related degeneration (AMD) patients.

The final appraisal determination (FAD) recommendation was based on the results from Novartis’ phase III HAWK and HARRIER trials, in which Beovu met the primary endpoint.

This included demonstrating improvements in best-corrected visual acuity (BCVA) from baseline that were non-inferior to Regeneron’s Eylea (aflibercept) at week 48.

Additionally, approximately 20% of Beovu-treated patients gained at least 15 letters at week 48 and vision gain was observed as early as four weeks into the trial and sustained over the course of the study.

“Today’s positive NICE recommendation represents an important advancement for people in England and Wales living with wet AMD. This decision not only means people with wet AMD have access to a treatment option that has the potential to maintain their vision, but also offers to minimise treatment burden and hospital visits,” said Chinmay Bhatt, managing director UK, Ireland & Nordics for Novartis Pharmaceuticals.

“This is more vital than ever to help relieve pressure on healthcare systems. We are working closely with the NHS to ensure eligible patients can start benefiting from brolucizumab as soon as possible,” she added.

According to Novartis, macular disease – including wet AMD – is the biggest cause of sight loss in the UK. Wet AMD, which constitutes 40,000 new cases each year, is a long-term degenerative disease that causes changes in vision.

In wet AMD, ‘faulty’ blood vessels leak fluid and blood in the back of the eye which can permanently scar the macular and if left untreated, central vision can gradually worsen.

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Beovu (brolucizumab) as a routine NHS treatment for wet age-related degeneration (AMD) in adults.

The final appraisal determination (FAD) recommendation was based on the results from Novartis’ phase III HAWK and HARRIER trials, in which Beovu met the primary endpoint.

This included demonstrating improvements in best-corrected visual acuity (BCVA) from baseline that were non-inferior to Regeneron’s Eylea (aflibercept) at week 48.

Additionally, approximately 20% of Beovu-treated patients gained at least 15 letters at week 48 and vision gain was observed as early as four weeks into the trial and sustained over the course of the study.

“Today’s positive NICE recommendation represents an important advancement for people in England and Wales living with wet AMD. This decision not only means people with wet AMD have access to a treatment option that has the potential to maintain their vision, but also offers to minimise treatment burden and hospital visits,” said Chinmay Bhatt, managing director UK, Ireland & Nordics for Novartis Pharmaceuticals.

“This is more vital than ever to help relieve pressure on healthcare systems. We are working closely with the NHS to ensure eligible patients can start benefiting from brolucizumab as soon as possible,” she added.

According to Novartis, macular disease – including wet AMD – is the biggest cause of sight loss in the UK. Wet AMD, which constitutes 40,000 new cases each year, is a long-term degenerative disease that causes changes in vision.

In wet AMD, ‘faulty’ blood vessels leak fluid and blood in the back of the eye which can permanently scar the macular and if left untreated, central vision can gradually worsen.