Posted by Michael Wonder on 09 Sep 2019
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
9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly dosing regimen.
Allergan and Molecular Partners today announced that the U.S. FDA has accepted a biologics license application and the EMA has validated a marketing authorisation application for Abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular (wet) age-related macular degeneration.
The FDA is expected to take action on the application mid-2020. A decision from the European Commission is expected in the second half of 2020.
