AbbVie’s first post-merger Allergan drug pitch strikes out with the FDA as regulators turn thumbs down on Lucentis challenger
Allergan has received its first FDA decision since officially becoming a part of AbbVie. And it’s bad news.
Regulators have spurned abicipar, the neovascular age-related macular degeneration (wet AMD) drug that Allergan chief Brent Saunders had touted as one of four “expected” approvals just before announcing the $63 billion sale.
The company said the complete response letter took issue with “the rate of intraocular inflammation” observed after administration of the anti-VEGF injection (2mg/0.05 mL) — which translates to an unfavorable benefit-risk ratio.
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