Molecular Partners and Allergan, an AbbVie Company 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). Abicipar pegol was licensed to Allergan from Molecular Partners in May 2011.
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.”
In the most positive scenario the FDA will request additional data. If these data are convincing the application process including milestone payments for Molecular Partner will be delayed by at least a year. Other programs of Molecular Partners for example in oncology or the recently launches anti-COVID-19 therapeutic program based on its “DARPin” platform are not affected.
(Press release / SK)