Mon - Fri 10:00-18:00
Johannesburg, Fourways

AbbVie: FDA Issues Complete Response Letter To BLA For Abicipar Pegol

(RTTNews) – Allergan, an AbbVie Company (ABBV), and Molecular Partners announced the FDA has issued a Complete Response Letter to the Biologics License Application for Abicipar pegol, an investigational DARPin therapy for patients with neovascular age-related macular degeneration.

The Response Letter 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. AbbVie plans to meet with the FDA to discuss the comments and decide next steps.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Leave a Reply

Select your currency
ZAR South African rand