FDA Accepts BLA for Abicipar Pegol for Neovascular Age-Related Macular Degeneration

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for abicipar pegol (Allergan), an investigational DARPin (designed ankyrin repeat proteins) therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD).

Abicipar pegol is comprised of DARPin molecules, which are part of a new investigational class of binding protein. It works by binding to and inhibiting the biologic activity of human vascular endothelial growth factor (VEGF) factor A with high affinity and specificity.  This results in the prevention of neovascularization and vessel permeability in the eye. 

The BLA was based on data from two identical phase 3 trials (CEDAR and SEQUOIA) that evaluated the efficacy and safety of abicipar pegol (administered on day 1, week 4, and week 8, then either every 8 weeks or every 12 weeks) compared with ranibizumab (Lucentis) monthly in treatment-naive patients with nAMD. The primary end point for both studies was the proportion of patients with the best corrected visual acuity (BCVA) change from baseline ≤15 letters in the study eye at Week 52.

Results demonstrated abicipar pegol to be noninferior with similar efficacy after 6 or 8 injections compared with 13 ranibizumab injections at 52 weeks. Regarding safety, the overall adverse events were similar among the 3 treatment arms.

“The FDA filing acceptance marks an important milestone for the DARPin technology as abicipar becomes our first DARPin candidate to receive filing acceptance by the FDA,” commented Michael T. Stumpp, COO of Molecular Partners. “We’re excited for the potential abicipar holds to become a true quarterly dosed anti-VEGF treatment in patients with nAMD to provide vision gains and improved quality of life.”

The FDA is expected to make a decision on the BLA mid-2020. 

For more information visit allergan.com.