Eylea is being reviewed as a treatment for retinopathy in premature infants.
The FDA has granted pediatric exclusivity to Eylea (aflibercept), which currently under regulatory review for retinopathy of prematurity (ROP) in preterm infants. Retinopathy of prematurity is a leading cause of blindness in children, and each year between 1,100 and 1,500 infants develop the disease. The target action date for the FDA decision is Feb. 11, 2023, and U.S. market exclusivity has been extended by an additional six months through May 17, 2024.
Bayer and Regeneron are collaborating on the global development of Eylea, and Regeneron maintains exclusive rights in the United States.
Eylea is currently available to treat patients with age-related macular degeneration, diabetic macular edema and diabetic retinopathy. It is a VEGF inhibitor that is injected into the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye.
The pediatric exclusivity determination is based on data from two phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA’s request to evaluate the use of Eylea as a treatment for retinopathy of prematurity in preterm infants. The two phase 3 trials also formed the basis of a supplemental biologics license application. The lead sponsors of the trials were Regeneron for BUTTERFLEYE and Bayer for FIREFLEYE.
Eylea is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More