Regeneron Eyes Earlier FDA Decision on Higher-Dose Eylea

Pictured: Financial graph overlaid on stacks of coins/iStock, Sakorn Sukkasemsakorn

Pictured: Financial graph overlaid on stacks of coins/iStock, Sakorn Sukkasemsakorn

The FDA will make its decision regarding a higher-dose regimen of Eylea (aflibercept) in the third quarter of this year, much earlier than market expectations, Regeneron revealed Thursday during its second-quarter earnings report.

In June 2023, the regulator denied Regeneron’s application for an 8-mg Eylea dose given at 12-week or 16-week intervals, citing issues with vial-filling following an inspection of a third-party contract manufacturer. Crucially, the FDA did not mention any safety or efficacy problems in its Complete Response Letter, nor did it raise concerns regarding labelling, trial design, or drug substance manufacturing.

Regeneron has since spoken to Catalent, the third-party service provider, and expects the additional data requested by the FDA to be submitted within the month. The regulator has indicated that it will prioritize the review of this submission and should arrive at a decision by the third quarter.

“The FDA said they will strive to complete their review expeditiously,” Regeneron CEO Leonard Schleifer said in an investor call Thursday morning, adding that the regulator may still need to extend the review period by up to three months, but will nevertheless “continue to prioritize the review and complete it as early as possible.”

Company shares rose 2.6% in premarket trading Thursday in reaction to the news.

During the second quarter, Eylea brought in $1.5 billion for Regeneron, down approximately 7% from its $1.62 billion revenue during the same period last year. This new approval could help the company bump Eylea’s sales while also helping patients adhere to their treatment schedules better.

Eylea, Regeneron’s blockbuster eye injection, is a recombinant fusion protein that blocks both VEGF-A and PLGF. It is approved for wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy and macular edema after retinal vein occlusion.

In its current label, however, Eylea can only be given as a 2-mg formulation, initially given monthly before being spread out to every eight weeks. By increasing the dose to 8 mg, Regeneron hopes to administer Eylea every 12 or 16 weeks. Data from two pivotal studies showed that this investigational regimen was not only as safe and effective as the current approved schedule, but it was also easy for patients to maintain.

Despite taking a 7% hit to sales for Eylea, Regeneron nevertheless beat analyst expectations overall for the second quarter. The company reported total revenues of nearly $3.16 billion in the quarter, up 11% from its $2.86 billion earnings during the same period last year. This was driven in part by better sales for its skin cancer treatment Libtayo (cemipilimab), cardio asset Praluent (alirocumab) and homozygous familial hypercholesterolemia medicine Evkeeza (evinacumab).

Collaboration revenues also contributed to Regeneron’s better financial results in the second quarter, particularly a 39% jump in its earnings from Sanofi, driven by a 33% surge in the sales of Dupixent (dupilumab). The allergy medicine, jointly developed by Regeneron and Sanofi, earned $2.79 billion in the quarter, up 33% versus the same period last year.

Also during its second-quarter report, Regeneron revealed that in an early-stage cancer study, two patients died after being treated with a combination of full-dose Libtayo and REGN5678, an investigational costimulatory bispecific antibody. The company is discontinuing enrollment into this treatment arm and will further study combining REGN5678 with lower doses of Libtayo.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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