(RTTNews) - Allergan plc (AGN) and Molecular Partners said that the U.S. Food and Drug Administration has accepted a Biologics License Application or BLA and the European Medicines Agency or EMA has validated a Marketing Authorisation Application or MAA for Abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD).
The FDA is expected to take action on the BLA mid-2020. A decision from the European Commission is expected in the second half of 2020.
The BLA and MAA filings are based on data from two Phase 3 trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.
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