Regeneron is holding on tight to its Eylea crown despite the drug’s approval more than a decade ago and new competition crowding the field.
In the third quarter, Eylea delivered another record sales performance, generating $1.63 billion in the U.S., an 11% increase from the same period last year. That was despite the rollout of Roche’s Vabysmo, which is viewed as a major threat to the Regeneron anti-VEGF therapy.
Meanwhile, Eylea recently secured a coveted pediatric exclusivity extension, adding another six months to its reign before biosimilars come knocking. And the company is not done yet with the drug.
In a closely watched trial, Eylea recently hit its goals in clinical trials assessing a high-dose formulation designed to last 12 and 16 weeks in patients with diabetic macular edema and neovascular age-related macular degeneration.
Regeneron now plans to use a previously granted priority review voucher to expedite the review for the 8-mg regimen of Eylea, CEO Leonard Schleifer, M.D., Ph.D., told investors during an earnings call Thursday. The company will submit for approval by the end of the year, eyeing a potential approval in August 2023, he said.
While Eylea is Regeneron’s biggest moneymaker, that’s not all the company has cooking. Another huge product for the company is the Sanofi-partnered Dupixent, which also posted record sales during the quarter. That product has been on a roll, recently picking up a new indication in prurigo nodularis.
A king doesn’t come without competition. Eli Lilly’s rival anti-IL-13 antibody, lebrikizumab, has been proving its worth in clinical trials in treating atopic dermatitis. But according to Regeneron, the market has room for competition.
Market leaders have an advantage when new products launch, Schleifer added on the call.
“When you’re so far ahead, when you have a really differentiated profile, you have an advantage,” Schleifer said. “Obviously, Lilly’s a fine company. They know what they’re doing. But as I said, there’s room. Frequently when new, good drugs come to market, there is a growth of the market."
On the R&D front, the company remains “bullish,” said Bob Landry, chief financial officer of Regeneron. Altogether, 35 programs are in clinical development at the company, including cancer drugs such as Libtayo.
Libtayo's application in newly diagnosed non-small cell lung cancer has already passed an original FDA target action date in September. Regeneron previously tied the delay to an FDA “travel complication” when scheduling a clinical trial site inspection in Eastern Europe. The company didn’t offer any update on the FDA application during the third-quarter earnings call.