Regulatory Regeneron receives FDA approval for longer-lasting vision loss medication

Regeneron receives FDA approval for longer-lasting vision loss medication

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The recent approvals signal a swifter turnaround for Regeneron than what analysts on Wall Street had initially anticipated following the rejection of the high-dose Eylea treatment in June. The FDA’s initial rejection had stemmed from a manufacturing issue identified at a third-party contractor’s facility responsible for the vial-filling of the medication. Market analysts had expressed concerns about potential extended delays, as past instances with other companies facing similar obstacles had taken up to nine months to rectify.

Such a prolonged setback would have posed significant challenges for Regeneron. A rival drug produced by Roche, known as Vabysmo, had been progressively gaining traction against Eylea, which has traditionally held a dominant position in the age-related macular degeneration (AMD) treatment market and has been a primary revenue source for Regeneron. Additionally, the impending threat of biosimilar competitors loomed large, with the first of these competitors projected to launch the following year.

However, during a recent conference call, Regeneron executives conveyed that the FDA was actively and promptly addressing the manufacturing issue. They also indicated that the reviews of both the high-dose Eylea and Veopoz were interconnected, as both drugs shared the same manufacturing line. With these approvals, the company now faces the test of whether its novel drug can effectively withstand mounting competition. Unlike the standard Eylea administered once every two months for AMD, the high-dose variant allows for less frequent administration following an initial regimen. Patients suffering from AMD or diabetic macular edema (DME) can extend the interval between shots to two to four months, while diabetic retinopathy patients can receive shots every two to three months.

Regeneron has set the price for the new version at $2,625 per vial, as stated by the company. This price point surpasses Eylea’s cost of $1,850 per vial, as well as Vabysmo’s price of $2,190 per vial. However, Regeneron’s statement highlights that the yearly cost of the new version is expected to be “within the range of, or lower than” that of Eylea, contingent upon factors such as the patient’s prescribed dosing schedule.

Analyst Brian Abrahams from RBC Capital Markets acknowledged that achieving this milestone while facing a relatively modest competitive challenge from Vabysmo is a positive outcome. Nevertheless, he cautioned that various factors must align favorably for Regeneron to maintain its market share. Questions remain about the speed of adoption of the new drug by healthcare professionals in light of the impending arrival of biosimilars and whether physicians will transition patients already stabilized on standard Eylea treatment.

Drawing from surveys of retinal specialists, analyst Christopher Raymond from Piper Sandler estimated that the Eylea franchise could generate annual U.S. revenue ranging from $6 billion to $7 billion between 2023 and 2025, following last year’s U.S. sales of approximately $6.3 billion.

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