Novartis raises the temp on Eylea rivalry with head-to-head trial win for Beovu in diabetic macular edema
Regeneron’s anti-VEGF Eylea has long dominated its market, but competitors are looking to dethrone the king — particularly Novartis’ latecomer Beovu. Hampered by prior safety concerns, Novartis has set Eylea directly in its sights with a pair of non-inferiority studies for Beovu that could help it get over the line in macular edema.
Novartis’ Beovu matched Regeneron’s anti-VEGF Eylea a year after treatment at improving diabetic macular edema patients’ eyesight in the drug’s second head-to-head swing at the market leader, Novartis said Tuesday.
In the Phase III Kestral trial — a complement to the prior Kite study — patients receiving a 6-mg dose of Beovu every three months saw similar improvements in eyesight, including central subfield thickness, compared with patients dosed with 2 mgs of Eylea, Novartis said. In a 12-week follow-up period, Beovu continued to match Eylea’s results in improving patients’ eyesight.
The top-line Kestral results come within months of the early Kite study readout, which also showed Beovu matched Eylea’s efficacy in diabetic macular edema. Eylea is the easy market leader in macular edema, where Beovu is currently chasing an FDA approval. Novartis’ drug hit the market back in October 2019, scoring an FDA approval in wet age-related macular degeneration (AMD).
Chasing Eylea and its $1.32 billion in third-quarter sales will be no easy task for Novartis, particularly after an unfortunate Beovu label update back in September added information on retinal vasculitis and retinal vascular occlusion, which can cause blindness. It’s not quite a black-box warning, but it could be enough to deter physicians willing to give the newer drug a shot; Novartis has said it’s convened a panel of experts to examine the problem.
In the meantime, the Swiss pharma said there were no new safety signals in the Kestral study, backing up its stable safety data from the Kite study. Both Beovu and Regeneron are delivered by intravitreal injection directly into the eye.
On top of its pursuit of macular edema, Novartis is also hoping to take Beovu into retinal vein occlusion and proliferative diabetic retinopathy as it hunts a market Eylea has long dominated. The drug snared $51 million in sales in the third quarter and has bagged approvals in 46 countries as of September.
Prior to the new safety flags, Novartis touted Beovu’s less onerous dosing regimen, which requires monthly injections for the first three months of treatment before switching over to a once-every-12-weeks schedule. Eylea, meanwhile, requires the monthly injection through month three with follow-up injections needed every eight weeks.