Allergan and Molecular Partners’s Abicipar pegol DARPin therapy was accepted by FDA in the USA, and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA), for patients with neovascular (wet) age-related macular degeneration (nAMD).
Allergan said 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.
David Nicholson, Chief Research and Development Officer, Allergan, said: “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.”
Michael T. Stumpp, COO of Molecular Partners, said: “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. 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.”