NMPA (China) accepted a submission for aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration
Bayer announced that the Center for Drug Evaluatio (CDE) of China’s National Medical Products Administration (NMPA) accepted the submission of an application for regulatory approval of aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration (nAMD).
Study data are now under review by the regulatory body in China. The application is based on positive results from the phase III PULSAR trial in nAMD, in which aflibercept 8 mg met its primary endpoint of non-inferiority in best corrected visual acuity (BCVA) changes compared to Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval at week 48. Aflibercept 8 mg demonstrated unprecedented durability with the vast majority of patients maintaining 12- or 16-week dosing intervals.
Eylea HD (aflibercept 8 mg) has been approved for use by the FDA in August 2023. To date, Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) has been approved in the EU, Japan and other markets for the treatment of nAMD and DME. Bayer has submitted regulatory applications for aflibercept 8 mg in additional markets.
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