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Novartis bags US okay for Lucentis follow-up Beovu in wet AMD

Head-to-head trial with rival Eylea could boost sales

Novartis

The FDA has approved Novartis’ new VEGF inhibitor Beovu as a new treatment option for patients with the wet form of age-related macular degeneration (AMD), a leading cause of blindness.

The green light for Beovu (brolucizumab) is a boost for Novartis as it tries to defend its wet AMD franchise, currently represented by $2bn-plus VEGF inhibitor product Lucentis (ranibizumab) which is starting to see its growth tail off.

Novartis’ drug was the first VEGF inhibitor to reach the market for wet AMD but is facing the triple challenge of Bayer/Regeneron’s rival drug Eylea (aflibercept) – now the market leader – as well as off-label use of Roche’s Avastin (bevacizumab) and patent expiries looming in the US next year and in 2022 in Europe.

Roche sells Lucentis in the US and made $1.7bn from the product last year, but Eylea is currently the dominant player with Regeneron reporting $4bn in US sales last year and Bayer adding another $2.1bn from other markets.

Beovu is key to reinforcing its franchise as it offers less-frequent administration, with eight to 12 weeks between injections into the eye, and the potential to extend that to 16 weeks via a protocol known as treat-and-extend (TAE).

That compares to four to eight week dosing with Eylea, and every month with Lucentis, and in trials, around half of patients on Beovu were maintained with three-monthly dosing.

Moreover, Novartis’ drug outperformed Eylea in head-to-head clinical trials when it came to reducing fluid in the retina – a key objective of treatment for wet AMD which is caused by an excess in VEGF that leads to abnormal growth of blood vessels in the back of the eye.

The Swiss group is running another head-to-head study of Beovu versus Eylea called TALON, that will compare the two drugs on clinical endpoints including visual acuity and treatment interval duration.

Novartis’ comparative studies have pitted Beovu against the standard Eylea administration regimen, and it’s worth noting that just over a year ago Regeneron bagged US approval for a 12-weekly regimen for the drug, with additional doses as needed.

Analysts think that Beovu has the potential to grow quickly to blockbuster sales levels, with GlobalData predicting it will exceed $4bn by 2026 and EvaluatePharma pegging it at a more modest $1.3bn in 2024.

The latter is a reduction on its earlier estimate and reflects greater competition in the AMD market as generics of the first-generation antibodies start to appear as well as other challengers such as Roche’s bispecific antibody faricimab (RG7716), which targets VEGF and Ang-2 and is in phase 3 testing.

Article by
Phil Taylor

8th October 2019

From: Regulatory

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