Bayer Submits Marketing Application for Aflibercept Intravitreal Injection Solution in China

Dec 15, 2023 11:28 CST Updated 11:29

Bayer

Pharmaceutical Product R&D Developer

▎WuXi AppTec Content Team Report

On December 15, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced,Bayer submittedAflibercept Intravitreal Injection SolutionSubmission of the listing application has been accepted. Public information shows,AfliberceptIt is a VEGF inhibitor,Developed by Bayer and Regeneron, it has previously beenApproved in multiple countries and regions, including China. In July this year, Bayer successively announcedAflibercept 8mgTreatment of diabetic macular edema and wet age-related macular degeneration achieves sustained vision improvement for the first time,And the dosing interval can be extended up to 24 weeks.Bayer has submitted the marketing application for Aflibercept 8mg in Europe and other markets.

Screenshot source:CDE Official Website

AfliberceptIt is a VEGF inhibitor.. As aFully humanized fusion protein，AfliberceptBy inhibiting the signaling pathways mediated by VEGF-A, VEGF-B, and placental growth factor (PLGF), it can suppress angiogenesis and reduce vascular permeability.Currently, aflibercept has been approved in many countries and regions, including China, for the treatment of neovascular age-related macular degeneration (wet AMD), retinal vein occlusion, diabetic macular edema, vision impairment caused by choroidal neovascularization due to pathologic myopia, and more.

In July this year, Bayer announced the two-year (96-week) results of the pivotal clinical trial PHOTON, which studiedAflibercept 8mgFor the treatment of diabetic macular edema (DME),Extend the dosing interval up to 24 weeks, compared with the current standard treatment Eylea (aflibercept 2mg) with a fixed 8-week dosing interval.

The study results show that, compared to the initial dosing of 5 times per month followed by an 8-week dosing interval of Aflibercept 2mg,After the first year of treatment, the dosing regimen for aflibercept 8mg was extended to up to 12 or 16 weeks after initially being administered monthly for 3 doses., achieving non-inferior improvement in best-corrected visual acuity (BCVA). Two-year data once again confirmed the efficacy, safety, and durability of the extended dosing regimen for aflibercept 8mg in DME treatment. In the trial, patients who were randomly assigned at baseline to receive either a 12-week or 16-week dosing regimen,After only three initial monthly loading doses, if pre-specified criteria are met, the dosing interval can be shortened or extended to a longer interval in the second year without affecting visual benefits.。

In August 2023, Bayer announced the treatment with Aflibercept 8mg again.Neovascular Age-Related Macular Degeneration (nAMD)Key Clinical Trial PULSAR 96-Week Results. Data once again confirms the sustained vision improvement with Aflibercept 8mg.Unprecedentedly extends the treatment interval up to 24 weeksCompared with the current standard treatment of aflibercept 2mg given every 8 weeks, its efficacy and safety are comparable.

According to reports,Bayer andRegeneronJointly developing AploneCiprol 8mg. RegeneronHas exclusive rights to Eylea (Aflibercept 2mg) and Aflibercept 8mg in the United States.Bayer has obtained exclusive marketing rights outside the United States, and the two companies equally share the sales profits of Aflibercept 2mg.

References:
[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Dec 15, 2023, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Aflibercept 8mg for Diabetic Macular Edema: First to Achieve Sustained Vision Improvement. Retrieved July 3, 2023, from https://mp.weixin.qq.com/s/e4S1N74TYwcllegQLCs5Kw

[3] Aflibercept 8mg for Diabetic Macular Edema: First to Achieve Sustained Vision Improvement. Retrieved Aug 22, 2023, from https://mp.weixin.qq.com/s/y_r4xsZINjmPSVRNGrUhqg

This article comes fromCompiled and edited by the WuXi AppTec content team based on publicly available information. Individuals are welcome to share this content on their social media feeds. For authorization to repost, please contact us via a message on the "MedView" WeChat official account. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.