Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration
DUBLIN, IRELAND – SEPT 9, 2019 – Allergan plc (NYSE: AGN), a leading global pharmaceutical
company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN),
a clinical-stage biotechnology company developing a new class of drugs known as DARPin®
platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted a
Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated a
Marketing Authorisation Application (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.