Regeneron pulled off a rare double play on Friday afternoon as it scored two FDA approvals—one under the radar and the other highly anticipated.
After the FDA signed off on Veopoz to treat ultra-rare Chaple disease, the United States regulator followed up with a nod for Regeneron’s high-dose version of blockbuster eye disease drug Eylea. The company revealed the approvals in a span of fewer than five hours.
While the endorsement for Veopoz opens the treatment up to an extremely small patient population of around 100 people globally, the green light for HD Eylea covers millions who have wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR). It also kicks off a much anticipated market clash with Roche.
The Eylea thumbs up comes after the FDA’s surprise rejection of the treatment in June because of an issue at the Bloomington, Indiana, plant of Regeneron’s contract manufacturer Catalent. Earlier this month, when Regeneron reported its second quarter earnings, the company said that Catalent would deliver information in the middle of August that could lead to approval by the end of the third quarter.
With the news, Regeneron’s share price increased from $794 on Friday afternoon to $826 by mid-morning on Monday, a 4% gain.
Regeneron and its Eylea partner Bayer are now set to take on Roche and its surging high-dose treatment Vabysmo, which has already gained blockbuster status this year despite being on the market for just 19 months.
Regeneron will charge $2,625 per dose of HD Eylea. This compares to a $2,190 price for a vial of Vabysmo, which is a 6 mg dose. Regeneron will launch high-dose Eylea immediately, with customers able to order it "early this week," a company spokesperson wrote in an email.
The approval "is a significant step for Regeneron to solidify its ophthalmology franchise and could allow for transitioning of new patient starts to Eylea HD ahead of new Eylea biosimilar entrants and increasing competition from Roche's Vabysmo,” Evan Seigerman, analyst with BMO Capital Markets, wrote in a note to clients.
With its ability to extend injection intervals for many patients to once every four months, Vabysmo hit the market with much fanfare as an alternative to Eylea, which requires a shot every two months. But now Regeneron has answered with its 8 mg version of Eylea, which trials suggest has superior staying power.
Earlier this month, results of a phase 3 study showed that 88% of patients receiving 8 mg injections of Eylea over a two-year period were able to extend their dosage to at least 12-week intervals. The PULSAR study, which was conducted by Bayer, also showed that 71% of patients met the extension criteria for longer dosing intervals, with 47% of patients reaching 20 or more weeks and 28% reaching the criteria for 24-week intervals.
As Regeneron has touted the staying power of Eylea, Roche has countered with results of trials that show that Vabysmo provides better drying of the retina than Eylea.
Last month, at the American Society of Retina Specialists conference, Roche subsidiary Genentech presented a post-hoc analysis of pooled data from two trials which showed Vabysmo led to less fibrosis than Eylea in patients with diabetic macular edema (DME). Post-hoc data from these and other trials also showed that more than half of AMD and DME patients who were treated every 16 weeks with Vabysmo met criteria to extend their dosing intervals to every 20 weeks.
As Vabysmo has gained steam—registering sales of 957 million Swiss francs ($1.1 billion) in the first half of this year—Eylea’s sales have stagnated. Its $1.5 billion generated in the second quarter matched the figure from the previous quarter and was a 7% decline from the same period in 2022.