February 13, 2018
Bayer receives first approval for Eylea® in China
Eylea is the first anti-VEGF drug approved in China for the treatment of visual impairment due to diabetic macular edema in patients with DMEBerlin, February 13, 2017 - Bayer announced today that Eylea® (aflibercept
solution for injection into the eye) has been approved by the Chinese State
Food and Drug Administration (CFDA) for the treatment of visual impairment due
to diabetic macular edema (DME). This is the first indication for Eylea
approved by the CFDA.
"With more than 110 million people in China suffering from diabetes, diabetic
retinopathy coupled with DME is a serious complication that can threaten the
vision of many working-age adults," said Dr. Joerg Moeller, Member of the
Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research
and Development. "The approval of Eylea in China in this important indication
is great news for the increasing number of patients."
Approximately one in three adults with diabetes worldwide - up to 93 million
people - are affected by diabetic retinopathy (DR), a complication of diabetes
which can lead to DME and blindness if left untreated. Without treatment, about
half of patients with DME lose more than two lines of vision within two years
of diagnosis, as measured on the Early Treatment Diabetic Retinopathy Scale
(ETDRS) eye chart, which can impact their ability to perform important daily
activities such as working and driving. The results of three phase 3 studies -
including more than 1200 patients - were very encouraging. The majority of
patients with visual impairment due to DME experienced a significant, greater
than two-line, improvement in visual acuity with aflibercept solution for
injection, also approved under the brand name Eylea.
Outside of China Eylea has been approved in the majority of countries for five
indications to treat patients with visual impairment due to: neovascular
age-related macular degeneration (wet AMD) due to retinal vein occlusion (RVO;
branch RVO or central RVO), and diabetic macular edema (DME). Eylea has also
been approved for the treatment of myopic choroidal neovascularization. Over 16
million doses of Eylea have been administered since launch worldwide.
Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global
development of Eylea. Regeneron maintains exclusive rights to Eylea in the
United States. Bayer has licensed the exclusive marketing rights outside the
United States, where the companies share equally the profits from sales of
Eylea, except for Japan where Regeneron receives a percentage of net sales.
About Diabetic Macular Edema
Diabetic macular edema (DME) and diabetic retinopathy (DR) are common
microvascular complications in people with diabetes. Diabetic retinopathy is a
disease affecting the blood vessels of the retina. DME occurs when fluid leaks
into the center of the macula, the light-sensitive part of the retina
responsible for sharp, direct vision. Fluid in the macula can cause severe
vision loss or blindness.
Visual impairment due to DME is estimated to affect 3-4% of people with
diabetes and is therefore the most frequent cause of blindness in young and
mid-aged adults in most developed countries. As the incidence of diabetes has
been steadily climbing, experts from around the world expect that the number of
people impacted by DME will also grow.
About VEGF and Eylea® (aflibercept solution for injection into the eye)
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.
Eylea® 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.
Aflibercept acts as a soluble decoy receptor that binds VEGF-A and placental
growth factor (PGF) and thereby can inhibit the binding and activation of their
cognate VEGF receptors.
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