Allergan Issued FDA Complete Response Letter for Eye-Care DrugBy
Allergan, an AbbVie Company, and Molecular Partners, a Zurich-based clinical-stage biopharmaceutical company, have been issued a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA) for their biologics license application (BLA) for Abicipar pegol, an investigation drug for treating neovascular (wet) age-related macular degeneration (nAMD).
The CRL indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit–risk ratio for treating AMD. AbbVie says it plans to meet with the FDA to discuss the agency’s comments and determine next steps.
Molecular Partners and Allergan entered into a broad discovery alliance in ophthalmology in 2012 to develop multi-DARPin molecules, Molecule Partners’ proprietary single-domain proteins, and broadened the initial collaboration on Abicipar in 2018. DARPin molecules are derived from naturally occurring binding proteins that consist of repeat sequences with capping structures at each end of the protein. Allergan became part of AbbVie with AbbVie’s completion of its $63-billion acquisition of Allergan in May (May 2020).