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

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.

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