Bayer's High-Dose Eylea 8mg (Aflibercept) Accepted for Review by China's NMPA Following UK Approval
核心洞察
China's National Medical Products Administration (搜索) (NMPA) has accepted Bayer's application for Eylea 8mg (aflibercept) to treat neovascular age-related macular degeneration (搜索) for regulatory review.
The UK's Medicines and Healthcare products Regulatory Agency (搜索) (MHRA) recently approved Eylea 8mg for both wet AMD (搜索) and diabetic macular edema (搜索), adding to existing approvals in the US, EU, and Japan.
Phase III PULSAR trial results demonstrated that aflibercept 8mg maintained non-inferior visual acuity compared to the standard 2mg dose, while allowing most patients to extend treatment intervals to 12 or 16 weeks.
Bayer has reached another regulatory milestone for its high-dose formulation of aflibercept, as the Chinese National Medical Products Administration (搜索) (NMPA) has accepted the company's application for Eylea 8mg for review. The submission seeks approval for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in the Chinese market.
This development follows the recent approval of Eylea 8mg by the UK's Medicines and Healthcare products Regulatory Agency (搜索) (MHRA) on January 19, 2024. The MHRA granted authorization for two indications: neovascular age-related macular degeneration (搜索) and visual impairment due to diabetic macular edema (搜索) (DMO (搜索)).
Strong Clinical Evidence Supports Global Regulatory Submissions
The NMPA submission is based on positive results from the Phase III PULSAR trial in nAMD patients. In this pivotal study, aflibercept 8mg met its primary endpoint of non-inferiority in best corrected visual acuity (BCVA) changes compared to the standard Eylea 2mg formulation at week 48, while maintaining a fixed 8-week treatment interval.
Notably, the higher-dose formulation demonstrated significant improvements in treatment durability. The majority of patients receiving aflibercept 8mg were able to maintain extended dosing intervals of 12 or 16 weeks between treatments, potentially reducing the treatment burden for patients with chronic retinal conditions.
Global Regulatory Status
The high-dose formulation has already secured several important regulatory approvals worldwide:
- The U.S. Food and Drug Administration (FDA) approved Eylea HD (aflibercept 8mg) in August 2023
- The European Union has granted marketing authorization for the treatment
- Japanese regulatory authorities have approved the medication
- Additional markets have also provided regulatory clearance
Bayer continues to pursue approvals in other markets globally, with the NMPA submission representing an important step toward making this treatment option available to patients in China.
Clinical Significance
The higher concentration formulation of aflibercept offers potential advantages for patients with retinal disorders. By extending the time between treatments while maintaining comparable efficacy to the standard dose, the 8mg formulation may reduce the treatment burden for patients who require long-term therapy.
Neovascular AMD and diabetic macular edema (搜索) are leading causes of vision loss worldwide. These conditions often require regular intravitreal injections to preserve vision, creating significant treatment burden for patients. The development of longer-acting therapies represents an important advancement in addressing this challenge.
As regulatory reviews continue in China and other markets, healthcare providers and patients await additional options for managing these sight-threatening retinal conditions with potentially reduced treatment frequency.