ARTICLE | Company News
Delay for Regeneron’s 12-week Eylea regimen
August 13, 2018 4:45 PM UTC
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA issued a complete response letter to an sBLA for an every 12-week dosing schedule of Eylea aflibercept to treat wet age-related macular degeneration (AMD).
The company said the delay is the result of ongoing labeling discussions. Regeneron declined to disclose details, but said it expects to complete the discussions and receive a final action from FDA in about two months...