European drug regulators have followed in the footsteps of their Australian and US counterparts, following the approval of Novartis’ new anti-VEGF therapy.
On 17 February, the Swiss drug manufacturer announced the European Commission (EC) had approved Beovu (brolucizumab) for the treatment of neovascular age-related macular degeneration (nAMD).
According to the company, the therapy is now is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid compared with competing drug Eylea (aflibercept), which is distributed by Bayer.
Beovu is also said to allow eligible nAMD patients to begin a three-month dosing interval immediately after the loading phase.
The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein. It comes after an approval by the Australian Therapeutic Goods Administration on 28 January and the US Food and Drug Administration in October.
“Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease,” Ms Marie-France Tschudin, president Novartis Pharmaceuticals, said.
“We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimise treatments for patients based on disease activity.”
A key feature of Beovu has been its potential for extended dosing intervals, which the some in the ophthalmic community believe could be a key factor in helping reduce non-adherence rates.
In Australia, it is recommended for monthly injections for the first three doses. 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.
In the Hawk and Harrier clinical trials, in which Beovu was put head-to-head with Eylea, more than half of study participants were maintained on a three-month dosing interval, with the remaining patients treated on a two month schedule.
“Today’s approval is a step forward for patients in Europe who have been looking for a new treatment option which may help them maintain their sight – and their independence – for longer,” Retina International president Ms Christina Fasser said.
“This can really help to alleviate a burden, not only on the patient themselves, but also on those who care for them.”
Beovu has also received Swissmedic approval in Switzerland for the treatment of nAMD. Novartis also has regulatory filings submitted in Canada, Japan and Brazil.