Bayer receives positive CHMP opinion for Eylea ™ in the EU for treatment of preterm babies with retinopathy of punctuality
Recommendation is grounded on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT/ Retinopathy of punctuality( ROP) can lead to severe visual impairment and blindness/ Bayer will apply for a patent term extension for the patent covering aflibercept, the active component in Eylea ™, of six months once the European Commission adopts a decision for a marker extension of Eylea
The Committee for Medicinal Products for Human Use( CHMP) of the European Medicines Agency( EMA) has espoused a positive opinion for a marker extension for Eylea ™( aflibercept) for intravitreal injection 40 mg/ mL in a prefilled hype
( PFS) for the treatment of preterm babies with retinopathy of punctuality( ROP). The final decision from the European Commission on the marker extension is anticipated in the coming months. *
Presently treatment options are limited. Conventional treatment with ray photocoagulation is associated with the destruction of retinal towel, which may affect in significant long- term complications similar as high diplopia( hypermetropia) and supplemental vision loss.
“ At Bayer, we fete that families with unseasonable babies with retinopathy of punctuality are staying for new effective and well permitted treatment options to spare them from significant visual impairment and indeed blindness, ” saidDr. Christian Rommel, Member of the Executive Committee of Bayer s Pharmaceutical Division and Head of Research and Development. “ Timely treatment in this vulnerable pediatric patient population is pivotal and we hope that we will soon be suitable to give an fresh remedial option. ”
Encyclopedically, it’s estimated that each time roughly,000 babies born precociously, who survive the neonatal period, develop vision- hanging ROP. In more serious cases, ROP can lead to blindness secondary to retinal detachment.
“ The families of our youthful cases face not only the ruinous impact of a unseasonable birth but also the threat that their child may face a life with severe visual impairment. The FIREFLEYE study showed that treatment success with aflibercept0.4 mg was high and achieved with substantially a single injection per eye in unseasonable babies with severe retinopathy of punctuality, “ said ProfessorDr. Andreas Stahl, Head of the University Department of Ophthalmology, University Medical Center, Greifswald, Germany.
Bayer will apply for a patent term extension for the European patent covering aflibercept, the active component in Eylea, of six months once the European Commission adopts a decision for a marker extension of Eylea. Such an extension would protract the patent term for that patent to November 2025.
Bayer and Regeneron are uniting on the global development of aflibercept. Regeneron maintains exclusive rights to Eylea in the United States. Bayer has certified the exclusive marketing rights outside the United States, where the companies partake inversely the gains from deals of Eylea.
About Retinopathy of Prematurity( ROP)
In Japan, Eylea ®( aflibercept) intravitreal injection 40 mg/ mL is approved for the treatment of preterm babies with retinopathy of punctuality( ROP) since September 2022. Retinopathy of punctuality is a vascular complaint of the immature retina of preterm babies, characterized by deficient vessel growth which triggers elevated intraocular situations of vascular growth factor( VEGF) and abnormal vessel growth. crucial threat factors include low age and weight at birth. Mild ROP generally resolves spontaneously, while severe forms of ROP bear timely treatment. Conventional ray treatment( by photocoagulation) destroys retinal towel performing in complications similar as high diplopia( severe hypermetropia) and supplemental vision loss. The VEGF asset aflibercept fitted into the eye targets those elevated intraocular situations of VEGF.
About VEGF and aflibercept result for injection into the eye
Aflibercept 2 mg result for injection into the eye, also known under its brand name Eylea ®, has been approved in over 100 countries for five suggestions for grown-ups, which includes the treatment of neovascular( wet) age- related macular degeneration( nAMD) and the treatment of visual impairment due to macular edema following retinal tone occlusion( RVO; branch RVO or central RVO), diabetic macular edema( DME) and myopic choroidal neovascularization( myopic CNV). Over 58 million vials/pre-filled hypes
of Eylea have been vended since its launch worldwide, with further than 8 million case- times of experience and a well- established optical and systemic safety profile. Aflibercept 8 mg is investigational, and its safety and efficacity haven’t yet been estimated by any nonsupervisory authority.
Vascular Endothelial Growth Factor( VEGF) is a naturally being protein in the body. Its normal part in a healthy organism is to spark conformation of new blood vessels( angiogenesis) supporting the growth of the body’s apkins and organs. It’s also associated with the growth of abnormal new blood vessels in the eye, which parade abnormal increased permeability that leads to edema.
Aflibercept result for injection is a recombinant emulsion protein, conforming of portions of extracellular disciplines of mortal VEGF receptors 1 and 2, fused to the Fc portion of mortal IgG1 and formulated as an iso-bibulous result for intravitreal administration. Aflibercept acts as a answerable bait receptor that binds VEGF- A and Placental Growth Factor( PGF) and thereby can inhibit the list and activation of their connate VEGF receptors.
About Bayer
Bayer is a global enterprise with core capabilities in the life wisdom fields of health care and nutrition. Its products and services are designed to help people and the earth thrive by supporting sweats to master the major challenges presented by a growing and growing global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and produce value through invention and growth. The Bayer brand stands for trust, trustability and quality throughout the world. In financial 2021, the Group employed around,000 people and had deals of44.1 billion euros. R&D charges before special particulars amounted to5.3 billion euros.
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