Novartis' speedy brolucizumab review tees up battle with Eylea, Lucentis

Look out, Roche and Regeneron—Novartis eye candidate brolucizumab is on its way.

Monday, the FDA said it had granted the wet age-related macular degeneration (AMD) prospect its priority review status, setting it up for a quick trip down the regulatory pathway. And if it can grab an approval at the end of it, brolucizumab will step right up against Regeneron’s Eylea and Roche’s Lucentis.

Novartis, for its part, is hoping to witness that showdown as soon as possible. It played a priority review voucher to grab the speedy evaluation, which should set up brolucizumab for a decision by October. As Nikos Tripodis, Novartis Ophthalmology’s worldwide franchise head, recently told FiercePharma, Novartis is already staffing up on sales reps in key regions in anticipation of a green light.

The Swiss drugmaker is counting on data from two phase 3 trials, dubbed Hawk and Harrier, to bring brolucizumab to market. Those studies pitted the up-and-comer against Eylea to establish that Novartis’ med could hang with the Regeneron blockbuster in terms of efficacy, as measured by the studies’ endpoint, best-corrected visual acuity.

Brolucizumab actually topped Eylea in some secondary endpoints, reducing retinal fluid and central subfield thickness, a key measure of abnormal fluid accumulation and edema that can result in vision loss. But as one expert told Jefferies analyst Biren Amin at the time, "retinal dryness and slightly reduced injection burden were incremental advances but not game-changers."

Novartis, for its part, disagrees, and it’s hoping those study wins will help it match or beat the $1.38 billion in 2024 sales Evaluate Pharma projected for brolucizumab in February. But meanwhile, its rivals aren't just sitting around waiting for its challenge.

Roche, for one, is working on its own next-generation AMD contender in faricimab, a phase 3 prospect. And Regeneron is gunning for a new indication in diabetic retinopathy for Eylea, sales of which grew more than 10% last year to reach $4.07 billion.

The "Eylea franchise is certainly far from done," Regeneron CEO Len Schleifer said at the J.P. Morgan Healthcare Conference in January.

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