Allergan, Molecular Partners announce US FDA accepts BLA & EMA validates MAA for Abicipar pegol in patients with neovascular (wet) AMD
Allergan plc, a leading global pharmaceutical company with a heritage of more than 70 years in eye care, and Molecular Partners, a clinical-stage biotechnology company developing a new class of drugs known as DARPin platform, announced that the US 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.
"Acceptance of our marketing applications brings us one step closer to offering physicians and patients a new treatment option that has the potential to reduce patient visits and injections while achieving and maintaining vision gains with quarterly dosing," said David Nicholson, chief research and development officer, Allergan. "Today's announcement reinforces Allergan's continued commitment to eye care innovation and means patients are one step closer to receiving what we believe to be a transformative treatment that will help address unmet needs for nAMD patients."