BRIEF—FDA and EMA accept filing applications for Allergan's abicipar

Ireland-incorporated Allergan this morning announced that the US Food and Drug Administration and the European Medicines Agency have accepted a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively, for abicipar pegol in patients with neovascular (wet) age-related macular degeneration (nAMD).

Abicipar is a novel, investigational DARPin therapy with the potential to become the first true dosed anti-VEGF treatment in patients with nAMD to provide vision gains and improved quality of life. Two-year results from the CEDAR and SEQUOIA trials have been accepted as a late breaker during the retina sub-specialty day at AAO 2019.

Revenue expectations for the product are modest, withsell-side consensus forecasting 2024 abicipar sales at only $178 million.

The BLA and MAA filings are based on data from two Phase III trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50% fewer injections versus ranibizumab (13 versus 6) dosed monthly in the first year.