Novartis nabs FDA approval for hyped Eylea rival
As Regeneron’s Eylea stares down potential slow-death-by-generics, Novartis has nabbed a widely expected FDA approval for its own wet macular degeneration injection, Beovu (brolucizumab).
Novartis has been eyeing Regeneron patent expiration with the leering intensity of a prowling tiger. Before becoming CEO in 2017, Vas Narasimhan identified brolucizumab as one of four big late-stage drugs to watch, and in 2018 he named it one of the “core 5” in his list of 25 blockbusters.
The chunk the Swiss giant may carve out of Eylea’s $5 billion revenue shrank shortly after that 2018 projection as Regeneron stumbled its way into a surprise FDA approval to administer over 12 weeks.
Today’s FDA approval is also for a 12-week dose. It was won off two head-to-head, randomized phase III clinical trials that found “non-inferiority” for brolucizumab against Eylea (aflibercept) after year one. In HAWK, patients receiving brolucizumab improved on eye tests by 6.6 letters for a 6 mg dose and 6.1 letters for a 3 mg dose compared with 6.9 mg. In the HARRIER study, patients receiving 6 mg of brolucizumab improved by 6.9 letters compared with 7.6 letters for aflibercept. The two trials covered a combined 1817 patients.
Novartis touted the drug as the first to offer both greater fluid resolution than aflibercept and that can be prescribed with a three-month dosing interval immediately after a three-month loading phase.
Baird analyst Brian Skorney, though, wrote the announcement looked “meh,” He argued Beovu was unlikely to make a huge impact on Eylea given similar efficacy and dosage, and what appears to marginally worse safety data.
“Although the introduction of a competitive product should result in some market share loss, we believe concerns that it is leading Eylea sales over a cliff are overdone, especially in light of this label,” Skorney wrote.
Eylea’s patents will begin to expire in 2023 in the US and 2025 in Europe, although the US intellectual property estate will remain into 2032.
Wet macular degeneration, also known as age-related macular degeneration, is the leading cause of vision loss and blindness in people over 65 in North America, Europe, Australia and Asia.
Regeneron, cognizant of Eylea’s long-looming patent expiration, signed a billion-dollar R&D partnership with Alnylam this year to explore RNAi therapies, including for wet AMD. Inflammasome, a new Boehringer Ingelheim partner, is developing molecules for wet AMD treatment.