Regeneron Pharmaceuticals announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date
TARRYTOWN, NY, USA | August 16, 2011 | Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN – News) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date.
The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing, and controls (CMC) section of the BLA as a major amendment to the BLA. The new action date will give the agency additional time to review the information submitted.
About EYLEA
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body’s tissues and organs. However, in certain diseases, such as age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema.
EYLEA (aflibercept injection) for intravitreal use, also known as VEGF Trap-Eye, is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). EYLEA is a specific and highly potent blocker of these growth factors. EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA for the treatment of neovascular age-related macular degeneration (wet AMD), central retinal vein occlusion (CRVO), diabetic macular edema (DME), and other eye diseases and disorders. Bayer submitted an application for marketing authorization in Europe in wet AMD in June 2011.
Bayer HealthCare will market EYLEA™ (aflibercept injection) outside the United States, where the companies will share equally the profits from any future sales of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 75
Regeneron Pharmaceuticals announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date
TARRYTOWN, NY, USA | August 16, 2011 | Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN – News) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date.
The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing, and controls (CMC) section of the BLA as a major amendment to the BLA. The new action date will give the agency additional time to review the information submitted.
About EYLEA
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body’s tissues and organs. However, in certain diseases, such as age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema.
EYLEA (aflibercept injection) for intravitreal use, also known as VEGF Trap-Eye, is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). EYLEA is a specific and highly potent blocker of these growth factors. EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA for the treatment of neovascular age-related macular degeneration (wet AMD), central retinal vein occlusion (CRVO), diabetic macular edema (DME), and other eye diseases and disorders. Bayer submitted an application for marketing authorization in Europe in wet AMD in June 2011.
Bayer HealthCare will market EYLEA™ (aflibercept injection) outside the United States, where the companies will share equally the profits from any future sales of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 75
