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Allergan : FDA Accepts BLA And EMA Validates MAA For Abicipar Pegol

(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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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