BERLIN, Germany I July 26, 2013 I Bayer HealthCare today announced that VEGF Trap-Eye (aflibercept solution for injection) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). The decision of the European Commission is expected in the second half of 2013.
“This is great news for patients in Europe suffering from CRVO, which is a debilitating disease affecting patients‘ central vision,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “The potential loss of vision impacts patients‘ independence and not only affects patients but also their families. We hope to be able to offer these patients and their physicians this new treatment option shortly.”
VEGF Trap-Eye was approved under the brand name EYLEA® in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following CRVO in September 2012. EYLEA has also been approved in Europe, Japan, Australia, and several other countries for use in wet AMD.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except in Japan where Regeneron receives a royalty on net sales.
About Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in the United States and more than 66,000 people in major European countries are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of deoxygenated blood and fluid in the retina. This causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment may help decrease vascular permeability and edema in the retina in patients with CRVO.
About VEGF and VEGF Trap-Eye (aflibercept solution for injection)
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. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results.
VEGF Trap-Eye is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. VEGF Trap-Eye acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis. For additional information about the company, please visit http://www.regeneron.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at http://www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
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BERLIN, Germany I July 26, 2013 I Bayer HealthCare today announced that VEGF Trap-Eye (aflibercept solution for injection) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). The decision of the European Commission is expected in the second half of 2013.
“This is great news for patients in Europe suffering from CRVO, which is a debilitating disease affecting patients‘ central vision,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “The potential loss of vision impacts patients‘ independence and not only affects patients but also their families. We hope to be able to offer these patients and their physicians this new treatment option shortly.”
VEGF Trap-Eye was approved under the brand name EYLEA® in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following CRVO in September 2012. EYLEA has also been approved in Europe, Japan, Australia, and several other countries for use in wet AMD.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except in Japan where Regeneron receives a royalty on net sales.
About Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in the United States and more than 66,000 people in major European countries are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of deoxygenated blood and fluid in the retina. This causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment may help decrease vascular permeability and edema in the retina in patients with CRVO.
About VEGF and VEGF Trap-Eye (aflibercept solution for injection)
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. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results.
VEGF Trap-Eye is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. VEGF Trap-Eye acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis. For additional information about the company, please visit http://www.regeneron.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at http://www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
Post Views: 95
