m
Recent Posts
Connect with:
Friday / August 14.
HomeminewsThree Monthly Beovu (Novartis) Approved by TGA

Three Monthly Beovu (Novartis) Approved by TGA

Beovu (brolucizumab) has been approved by the Therapeutic Goods Administration (TGA) for the treatment of wet (neovascular) agerelated macular degeneration (nAMD) in Australia.

Developed by the Swiss medical company Novartis, this is the first approved anti-VEGF in Australia to offer the ability to maintain eligible wet AMD patients on a three month dosing interval directly after the monthly loading doses. Novartis is now working with the government to have the drug listed on the Pharmaceutical Benefits Scheme (PBS).

scientists are exploring and structuring their research and trials to address this issue in increasing durability and effectiveness of drugs and delivery systems

Dr Andrew Chang.

Regulatory approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferior best-corrected visual acuity (BCVA) change from baseline at year one (week 48) versus aflibercept.At year one, over half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER). The remaining patients in the study were treated on a two-month dosing schedule.1

Clinical Associate Professor of Sydney University and vitreoretinal ophthalmologist and surgeon, Dr Andrew Chang said ophthalmologists welcome the news of TGA approval for Beovu and look forward to accessing the drug to treat wet AMD – a leading cause of blindness.

He said Beovu adds to existing anti- VEGF drugs which are used to treat AMD complicated by neovascularisation (Lucentis, Eylea and Avastin). This will provide more treatment options in managing our patients.

“We currently have a number of effective drugs which block VEGF to reduce leakage and the growth of the new vessels. However, each drug has different molecular characteristics and pharmacokinetic behaviour in the human eye and body.

“Our experience2 is that some patients may respond better to one drug than another and furthermore, their response may alter during the course of treatment. Ophthalmologists may start off using one drug and reach a point where it seems to be less effective. The ophthalmologist may then consider switching to another which may prove to be more effective.”

Dr Chang said up to one third of patients may not respond optimally to treatment, and it is this group of patients that require intensive treatment with frequent visits to clinic for anti- VEGF injections over many years, causing a significant burden for the patient, their carers and the health system in general.

BURDEN OF TREATMENT DRIVES RESEARCH AND DEVELOPMENT

Dr Chang said recognition of this burden of treatment is now driving research and development.

“It has been a major advance to save sight in Australia with anti-VEGF drugs since 2007, but even more pleasing that pharmaceutical companies are now recognising the burden associated with intensive treatment is an important issue. As a consequence, scientists are exploring and structuring their research and trials to address this issue in increasing durability and effectiveness of drugs and delivery systems.

“The Hawk and Harrier trials give us data, for the very first time, for treatment up to three monthly intervals – these are the pivotal registration studies.”

Macular Disease Foundation Australia CEO, Dee Hopkins echoed Dr Chang’s sentiment. “Trials have shown that this new therapy may extend the duration between treatments for some patients with neovascular AMD. We hope that real world outcomes will result in reduced treatment burden on patients and improve persistence rates for sight saving treatment.”

References 

  1. Dugel P, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration [published online ahead of print]. Ophthalmology. 2019. 
  2. Broadhead G, Hong T, Chang AA. Treating the Untreatable Patient: Current Options for the Management of Treatment- Resistant Neovascular Age-Related Macular Degeneration. Acta Ophthalmologica 2014; 92(8):713-23.

DECLARATION

DISCLAIMER : THIS WEBSITE IS INTENDED FOR USE BY HEALTHCARE PROFESSIONALS ONLY.
By agreeing & continuing, you are declaring that you are a registered Healthcare professional with an appropriate registration. In order to view some areas of this website you will need to register and login.
If you are not a Healthcare professional do not continue.