R&D

Months after Regeneron secured FDA approval for 12-week Eylea regimen, Novartis buys speedy US review for its rival

Vas Narasimhan

Novartis’ brolucizumab could do to Regeneron’s Eylea what the flagship eye treatment did to Roche’s Lucentis, some experts have predicted. Vas Narasimhan has shouted from the rooftops the promise of brolucizumab even before his elevation to Novartis chief. On Monday, Novartis came one step closer to launching its challenge to Regeneron’s formidable blockbuster, securing a speedy review for brolucizumab for use in wet age-related macular degeneration (AMD), setting it up for approval by the end of this year.

Wet AMD is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America, Europe, Australia and Asia, impacting an estimated 20 to 25 million people globally.

Last August, the FDA allowed Regeneron $REGN to start marketing a 12-week regimen for Eylea for wet AMD patients, versus the original bi-monthly regimen. Brolucizumab is also a 12-week regimen, although Novartis $NVS has argued pivotal trial data suggests the drug was “consistently superior” to its Regeneron rival, which generated more than $4 billion in net US sales last year. 

Novartis secured the quick review after submitting a priority review voucher. The marketing application was largely based on data from two late-stage studies: the HAWK and HARRIER trials, in which the drug met the main goal by showing it was as effective as Eylea in improving visual acuity after two years of treatment. Key secondary endpoints assessments also showed significantly fewer brolucizumab patients with disease activity and retinal fluid, versus Eylea, Novartis said.  

“Given upcoming competition from brolucizumab, we sense that (Regeneron) management is open to providing discounts or rebates if necessary to maintain Eylea’s competition in case brolucizumab provides attractive financial terms,” Cowen’s Yaron Werber wrote in a note last month.

Yaron Werber

“With Roche’s faricimab coming in 2022/23 and Eylea biosimilars in Europe in 2025, the franchise is going to be facing pressure,” he added in a note published in February.

Meanwhile, Allergan’s $AGN abicipar is also in the mix for patients with wet AMD, having demonstrated non-inferiority to Lucentis given every 8 or 12 weeks in a pair of Phase III trials. But the rate of intraocular inflammation observed abicipar-treated patients in the MAPLE study were significantly higher than the rate observed in Lucentis and Eylea, which could limit its success as a real player, SVB Leerink analysts wrote in a note earlier in April.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
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Atlas Venture Cambridge, MA

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