High-dose aflibercept secured a regulatory victory in China as 6-month dosing nears European approval
Good news apparently comes in twos for Bayer (Leverkusen, Germany) and aflibercept 8mg.
The German pharma giant announced two regulatory developments for their high dose exudative retinal disease drug at the end of last week, with Chinese regulators approving the high-dose aflibercept for neovascular age-related macular degeneration (nAMD) and European regulators recommending extended 6-month treatment intervals.
China’s National Medical Products Administration (NMPA) approved Eylea 8mg for nAMD on May 22, while the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on May 23 for expanded treatment intervals of up to 6 months in both nAMD and diabetic macular edema.
READ MORE: FDA Grants Priority Review to Eylea HD for Macular Edema Following RVO
China opens the door
China’s Eylea 8mg approval for nAMD marks the drug’s entry into one of the world’s largest pharmaceutical markets.
The approval draws from the PULSAR Phase III pivotal trial data, where aflibercept 8mg achieved non-inferior visual acuity gains at 48 weeks compared to standard-dose aflibercept, with approximately 80% of patients maintaining their assigned 12-week and 16-week dosing intervals.
The Chinese decision adds to Eylea 8mg’s global footprint, which now spans more than 50 markets.
READ MORE: Bayer’s Eylea 8mg Makes Huge Regulatory Strides Worldwide
European interval extension
The European development is a strategically significant breakthrough in an intensifying debate over ultra-long treatment intervals with the drug.
The CHMP issued a positive opinion on May 23 recommending expanded treatment intervals of up to 6 months for both nAMD and diabetic macular edema. If approved by the European Commission, Eylea 8mg would be the only anti-VEGF treatment in the EU authorized for 6-month dosing intervals.
READ MORE: Bayer’s Aflibercept 8 mg Eyes Six-Month Stretch Between Treatments
The decision comes a month after the United States’ top regulatory body, the Food and Drug Administration, rejected Regeneron’s (New York, United States) bid for longer treatment intervals across the pond for all approved indications, including DME.
The rejection came in the form of a Complete Response Letter in response to Regeneron’s supplemental Biologics License Application (sBLA) seeking approval for intervals of up to 24 weeks. Regeneron has exclusive marketing rights to aflibercept in the United States, while Bayer markets the drug outside of the country.
READ MORE:FDA Rejects Regeneron’s sBLA to Extend EYLEA HD Dosing Interval
