Bayer announced today that the Drug Evaluation Center (DEC) of China's National Medical Products Administration (NMPA) has agreed to review an application for regulatory approval of aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration (AMD).
The study data are currently under review by the Chinese regulatory authority.
The application is based on positive results from a Phase III trial showing that aflibercept 8 mg met its primary endpoint of non-inferiority in terms of best change in corrected visual acuity (BCVA) compared with Eylea (aflibercept 2 mg).
At week 48 of the trial, aflibercept 8 mg, administered with extended treatment intervals (every 12 or 16 weeks), demonstrated visual acuity comparable to that of standard Eylea (aflibercept 2 mg) with a fixed treatment interval of 8 weeks, after three initial monthly doses.
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Bayer AG is one of the world's leaders in designing, producing, and marketing pharmaceutical products and agrochemicals. Net sales are distributed by product family as follows:
- agrochemicals (47.5%): herbicides, fungicides, insecticides, etc.;
- pharmaceutical products (39.1%): intended for the prevention and treatment of cardiovascular and respiratory diseases, diabetes, nervous system disorders, etc.;
- OTC products and nutritional supplements (12.7%);
- other (0.7%).
Net sales are distributed geographically as follows: Germany (5.7%), Switzerland (1%), Europe-Middle East-Africa (22.9%), United States (33.1%), North America (3.6%), China (7.6%), Asia-Pacific (8.9%), Brazil (9.6%), and Latin America (7.6%).
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