Posted by Michael Wonder on 26 Jun 2020
Allergan and Molecular Partners receive complete response letter from FDA on biologics license application for abicipar pegol
26 June 2020 - Allergan and Molecular Partners today announced that the U.S. FDA has issued a complete response letter to the biologics license application for abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration.
The letter from the FDA indicates that the rate of intra-ocular inflammation observed following administration of abicipar pegol 2 mg/0.05 mL results in an unfavourable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration.
AbbVie plans to meet with the FDA to discuss their comments and determine next steps.
