Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Currently, there are no FDA-approved systemic…
Regeneron Receives Complete Response Letter for Eylea Injection
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…
Regeneron And Sanofi To Lower Price Of Praluent Injection
Regeneron Pharmaceuticals and Sanofi announced they will lower the net price of Praluent (alirocumab) Injection in exchange for straightforward, more affordable patient access from Express Scripts. Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement significantly simplifies the documentation necessary to secure insurance coverage and may help reduce out-of-pocket costs…