Bayer receives positive CHMP opinion for Eylea™ in the EU for treatment of preterm infants with retinopathy of prematurity

Berlin, November 11, 2022 – The Committee for Medicinal Products for Human Exercise (CHMP) of the European Medicines Company (EMA) has adopted a certain understanding for a designate extension for Eylea^™ (aflibercept) for intravitreal injection 40 mg/mL in a prefilled syringe (PFS) for the therapy of preterm infants with retinopathy of prematurity (ROP). The final choice from the European Price on the designate extension is anticipated in the coming months.*

Currently therapy recommendations are microscopic. Used therapy with laser photocoagulation is connected to the destruction of retinal tissue, that may maybe well maybe pause up in basic long-term problems equivalent to excessive myopia (nearsightedness) and peripheral imaginative and prescient loss.

“At Bayer, we undercover agent that families with untimely infants with retinopathy of prematurity are looking out forward to original effective and properly tolerated therapy recommendations to spare them from basic visual impairment and even blindness,” talked about Dr. Christian Rommel, Member of the Govt Committee of Bayer`s Pharmaceutical Division and Head of Study and Pattern. “Wisely timed therapy on this prone pediatric patient inhabitants is a basic and we hope that we are going to soon be in a situation to present an extra therapeutic option.”

Globally, it is estimated that every 365 days approximately 50,000 infants born in attain, who live to declare the tale the neonatal length, originate imaginative and prescient-threatening ROP. In extra severe cases, ROP can lead to blindness secondary to retinal detachment.

“The families of our youngest sufferers face no longer easiest the devastating impact of a untimely birth nonetheless additionally the probability that their microscopic one can also face a life with severe visual impairment. The FIREFLEYE discover showed that therapy success with aflibercept 0.4 mg was as soon as excessive and carried out with mostly a single injection per peek in untimely infants with severe retinopathy of prematurity,“ talked about Professor Dr. Andreas Stahl, Head of the University Department of Ophthalmology, University Scientific Middle, Greifswald, Germany.

Bayer will discover for a patent term extension for the European patent keeping aflibercept, the energetic ingredient in Eylea, of six months as soon as the European Price adopts a decision for a designate extension of Eylea. Such an extension would lengthen the patent term for that patent to November 2025.

Bayer and Regeneron are participating on the worldwide boost of aflibercept. Regeneron maintains abnormal rights to Eylea in the us. Bayer has licensed the abnormal advertising and marketing and marketing rights initiating air the us, where the firms portion equally the earnings from gross sales of Eylea.

About Retinopathy of Prematurity (ROP)

In Japan, Eylea^® (aflibercept) intravitreal injection 40 mg/mL is authorised for the therapy of preterm infants with retinopathy of prematurity (ROP) since September 2022. Retinopathy of prematurity is a vascular disease of the immature retina of preterm infants, characterized by incomplete vessel boost which triggers elevated intraocular phases of vascular boost component (VEGF) and irregular vessel boost. Key probability factors embody low age and weight at birth. Gentle ROP continuously resolves spontaneously, while severe forms of ROP require properly timed therapy. Used laser therapy (by photocoagulation) destroys retinal tissue ensuing in problems equivalent to excessive myopia (severe nearsightedness) and peripheral imaginative and prescient loss. The VEGF inhibitor aflibercept injected into the peek targets these elevated intraocular phases of VEGF.

About VEGF and aflibercept resolution for injection into the peek

Aflibercept 2 mg resolution for injection into the peek, additionally known beneath its imprint title Eylea^®, has been authorised in over 100 nations for 5 indications for adults, which accommodates the therapy of neovascular (moist) age-connected macular degeneration (nAMD) and the therapy of visual impairment attributable to: macular edema following retinal vein occlusion (RVO; department RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularization (myopic CNV). Over 58 million vials/pre-stuffed syringes of Eylea had been sold since its launch worldwide, with more than 8 million patient-years of trip and a properly-established ocular and systemic security profile. Aflibercept 8 mg is investigational, and its security and efficacy possess no longer yet been evaluated by any regulatory authority.

Vascular Endothelial Increase Factor (VEGF) is a naturally occurring protein in the physique. Its fashioned role in a healthy organism is to situation off formation of original blood vessels (angiogenesis) supporting the growth of the physique’s tissues and organs. It is additionally connected to the growth of irregular original blood vessels in the peek, which point to irregular increased permeability that outcomes in edema.

Aflibercept resolution for injection is a recombinant fusion protein, consisting of parts of extracellular domains of human VEGF receptors 1 and a pair of, fused to the Fc fraction of human IgG1 and formulated as an iso-osmotic resolution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Increase Factor (PGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

About Bayer

Bayer is a worldwide enterprise with core competencies in the life science fields of health care and vitamin. Its products and services are designed to aid of us and the planet thrive by supporting efforts to grasp the basic challenges provided by a rising and aging global inhabitants. Bayer is committed to riding sustainable boost and producing a certain impact with its firms. At the identical time, the Neighborhood targets to enlarge its incomes energy and originate price via innovation and boost. The Bayer imprint stands for belief, reliability and quality all over the enviornment. In fiscal 2021, the Neighborhood employed around 100,000 of us and had gross sales of 44.1 billion euros. R&D bills earlier than special objects amounted to 5.3 billion euros. For more knowledge, traipse to www.bayer.com.

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Forward-Taking a seek for Statements

This launch can also relish forward-taking a seek for statements in line with fresh assumptions and forecasts made by Bayer management. Loads of known and unknown dangers, uncertainties and other factors may maybe well maybe lead to discipline fabric variations between the categorical future outcomes, monetary scenario, boost or efficiency of the company and the estimates given here. These factors embody these discussed in Bayer’s public reports which are on hand on the Bayer net site at www.bayer.com. The corporate assumes no liability by any potential to change these forward-taking a seek for statements or to conform them to future events or trends.

* Eylea is no longer yet authorised for ROP in the EU.