Regeneron’s EYLEA HD Receives FDA Review Period Extension
Regeneron Pharmaceuticals Updates on EYLEA HD FDA Review
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has recently shared an important update regarding EYLEA HD® (aflibercept) Injection 8 mg. The U.S. Food and Drug Administration (FDA) has extended the review timeline for two significant regulatory submissions. These submissions include a Prior-Approval Supplement (PAS) related to the EYLEA HD prefilled syringe, as well as a supplemental Biologics License Application (sBLA) aimed at expanding the drug's approved uses.
Understanding the Extended Review Period
The FDA decided to extend the action dates into the fourth quarter of 2025 after a major amendment was determined from recent findings during an inspection of a third-party manufacturing facility. After a comprehensive inspection at Catalent Indiana LLC, which has been acquired by Novo Nordisk A/S, additional information was provided that warranted further evaluation. This has led Regeneron to expect that, once the manufacturing issues are addressed, the FDA will act swiftly on these applications.
Current Availability of EYLEA HD
Despite the review period extension, EYLEA HD remains accessible in the U.S. through vial administration for patients. It has been authorized with dosage intervals that vary from every 8 to 16 weeks for patients dealing with conditions like wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Moreover, for individuals diagnosed with diabetic retinopathy (DR), the approved administration is every 8 to 12 weeks following three initial monthly doses.
Insights on EYLEA HD
EYLEA HD, introduced over a decade ago, has paved the way for better treatment approaches targeting serious chorioretinal vascular diseases. With a strong track record established through 16 pivotal clinical trials, EYLEA is a recognized treatment option for life-altering conditions. It addresses a spectrum of diseases affecting individuals from infancy, such as retinopathy of prematurity (ROP), to more mature age conditions, including diabetic macular edema (DME), diabetic retinopathy (DR), and wet age-related macular degeneration (wAMD).
Innovative Development of EYLEA HD
To meet the growing patient demands, EYLEA HD was developed with comparable efficacy and safety to EYLEA while minimizing injection frequency. Current approvals allow for its use in treating wAMD, DME, and DR, showcasing the commitment to innovation within Regeneron's offerings.
Collaboration Between Regeneron and Bayer AG
The partnership between Regeneron and Bayer AG to develop EYLEA HD further enhances the global reach of this treatment. While Regeneron holds exclusive rights to EYLEA and EYLEA HD within the U.S., Bayer holds marketing rights outside this jurisdiction. Both organizations jointly share the profits generated from EYLEA and EYLEA HD sales, demonstrating a strong collaborative effort aimed at maximizing patient access to these critical therapies.
Regeneron’s Commitment to Ophthalmology
At Regeneron, there is a fervent drive to innovate within eye care science. The team strives to enhance the eye health of millions affected by vision-threatening conditions. Their extensive expertise in angiogenesis, coupled with decades-long research endeavors, lays the groundwork for continuing innovation in developing new treatment options. The focus in ophthalmology includes serious eye diseases, such as geographic atrophy and glaucoma, alongside their commitment to ongoing clinical trials.
Safety and Indications for EYLEA HD
EYLEA HD® (aflibercept) Injection 8 mg is approved for various eye conditions. It is important to note that EYLEA is administered via injections and must be carefully monitored, particularly for patients who might face infections or other complications due to the treatment. It is crucial for patients and healthcare providers to work closely to navigate potential risks associated with the injections.
Side effects may include common occurrences such as light sensitivity and changes in vision. Patients are encouraged to discuss any concerns with their doctors proactively.
Frequently Asked Questions
What is EYLEA HD used for?
EYLEA HD is used to treat Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
Why has the FDA extended the review period for EYLEA HD?
The FDA extended the review period following significant findings during a manufacturing inspection that prompted additional information submissions.
Who developed EYLEA HD?
EYLEA HD was collaboratively developed by Regeneron and Bayer AG, with Regeneron maintaining exclusive rights within the U.S.
What potential side effects should patients be aware of while using EYLEA HD?
Common side effects include redness in the eye, increased eye pressure, cataracts, and temporary visual changes.
How does Regeneron contribute to advancements in ophthalmology?
Regeneron invests significantly in research and innovation in eye care to develop effective treatments for various eye diseases, committing to improve patient outcomes.
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