Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol
NORTH CHICAGO, Ill., June 26, 2020 – Allergan, an AbbVie Company (NYSE: ABBV), and
Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class
of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the
U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the
Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy
for patients with neovascular (wet) age-related macular degeneration (nAMD).
The letter from the FDA indicates that the rate of intraocular inflammation observed following
administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the
treatment of neovascular (wet) age-related macular degeneration (AMD). AbbVie plans to meet
with the FDA to discuss their comments and determine next steps.
“We continue to believe in the need for treatment options that provide patients with reliable vision
gains and less frequent dosing for the treatment of nAMD,” said Michael R. Robinson, M.D., Vice
President, Global Therapeutic Area Head, Ophthalmology, AbbVie. “We are committed to working
with the FDA to determine the appropriate next steps for Abicipar pegol.”
The global need for eye health services is projected to increase dramatically in the coming
decades, posing a considerable challenge to healthcare systems. Through building a strong,
active pipeline, which is focused on significant unmet needs in eye care, AbbVie is committed to
developing and delivering sustainable solutions that make a remarkable impact on people’s lives.