Due to ongoing labeling discussions the U.S. FDA has issued a complete response letter (CRL) regarding the Regeneron’s supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
The sBLA was based on the second year data from the View studies during which patients were treated with a modified 12 week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.
Eylea (aflibercept) Injection is a vascular endothelial growth factor (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 (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., Eylea is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.
Eylea is currently approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
Regeneron and Bayer AG collaborate on the global development and commercialization of Eylea. Regeneron maintains exclusive rights to Eylea in the U.S. Bayer has licensed the exclusive marketing rights outside the U.S., where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
(Source: Regeneron Pharmaceuticals, Inc.)
