FDA, European Medicines Agency advance abicipar pegol applications for wet AMD

The FDA has accepted a biologics license application and the European Medicines Agency has validated a marketing authorization application for abicipar pegol, an investigational DARPin therapy for wet age-related macular degeneration, Allergan and Molecular Partners announced in a press release.

The two filings are based on data from the CEDAR and SEQUOIA phase 3 trials, which assessed the efficacy and safety of abicipar compared with Lucentis (ranibizumab, Genentech). In both trials, abicipar showed similar efficacy in six or eight injections compared with 13 ranibizumab injections.

“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,” David Nicholson, chief research and development officer at Allergan, said in the release. “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 [neovascular] AMD patients.”

The FDA is expected to take action on the BLA in mid-2020, while the European Commission is expected to do so in the second half of 2020, the release said.

The FDA has accepted a biologics license application and the European Medicines Agency has validated a marketing authorization application for abicipar pegol, an investigational DARPin therapy for wet age-related macular degeneration, Allergan and Molecular Partners announced in a press release.

The two filings are based on data from the CEDAR and SEQUOIA phase 3 trials, which assessed the efficacy and safety of abicipar compared with Lucentis (ranibizumab, Genentech). In both trials, abicipar showed similar efficacy in six or eight injections compared with 13 ranibizumab injections.

“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,” David Nicholson, chief research and development officer at Allergan, said in the release. “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 [neovascular] AMD patients.”

The FDA is expected to take action on the BLA in mid-2020, while the European Commission is expected to do so in the second half of 2020, the release said.