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Novartis secures approval for AMD drug in Australia

Australia’s ophthalmic community has welcomed the approval of Novartis’ latest therapy for neovascular age-related macular degeneration (nAMD). Advocates hope the decision will lift treatment adherence rates across the country.

In Sydney this week, the multi-national pharmaceutical company announced the Therapeutic Goods Administration (TGA) had cleared its intravitreal injection therapy, Beovu (brolucizumab), for nAMD. The approval makes it the first approved anti-VEGF in Australia that can maintain eligible patients on a three-month dosing interval directly after three initial monthly loading doses.

The Australian approval follows in the footsteps of the US, which cleared the therapy in October. The drug is also on track for European approval in the coming months.

A key feature of Beovu has been its potential for extended dosing intervals, which the ophthalmic community believes could be a key factor in helping reduce non-adherence rates.

It is recommended for monthly injections for the first three doses, according to the TGA. Thereafter, the physician may individualise treatment to every two months for patients with disease activity, and every three months for those without disease activity. The physician may also further personalise the treatment where appropriate.

“The trials have shown this new therapy [Beovu] may extend the duration between treatments for some patients with neovascular age-related macular degeneration,” Macular Disease Foundation Australia CEO Ms Dee Hopkins told Insight.

“As the peak body representing the macular disease community, we hope that real world outcomes will result in reduced treatment burden on patients. Hopefully, this may further improve persistence rates for sight-saving treatment.

“It’s important patients have a choice of treatments, but it’s also important that treatment is accessible and affordable. Currently in Australia, there is a 20-25% non-adherence rate for [intravitreal injection] treatment in the first 12 months. I’m hopeful our sector can work collectively to reduce that number moving forward.”

Beovu is now the newest player in an expanding anti-VEGF market. However, its arrival comes at a challenging time as the sector grapples with an unpopular proposal to reduce the Medicare Benefits Schedule rebate and fee for intravitreal injections, a measure opponents say could cut stifle access to treatment.

It will compete with Roche’s Lucentis (ranibizumab), the pioneering anti-VEGF treatment that was listed on the Australian Pharmaceutical Benefits Scheme in 2007. Lucentis is also marketed by Novartis in markets outside the US.

Ophthalmologists will also be keen to see how Beovu measures up against Regeneron/Bayer’s Eylea (aflibercept), which itself is recommended for a treat-and-extend regimen of up to three to four months in some cases.

Australian regulators approved Beovu this week as a result of findings from the Phase III Hawk and Harrier clinical trials, in which Beovu demonstrated non-inferior best-corrected visual acuity change from baseline at year one compared with Eylea.

At year one, 56% of patients in Hawk and 51% in Harrier were maintained on the three-month dosing interval. The remaining patients were treated on a two-month dosing schedule.

“Beovu is a testament to our commitment here at Novartis to reimagine medicine for patients living with wet age-related macular degeneration” said Mr Richard Tew, general manager of Novartis Pharmaceuticals Australia and New Zealand. “We are delighted that Beovu is now registered in Australia.”

Associate Clinical Professor of Sydney University and vitreoretinal ophthalmologist and surgeon Dr Andrew Chang said ophthalmologists welcomed the TGA’s approval.

“We look forward to accessing this drug to treat our patients with wet age-related macular degeneration which is a leading cause of blindness in Australia,” he said.

More reading:

FDA clears Novartis’ new treatment for nAMD

Novartis targets Europe for next-generation AMD treatment