On October 2, 2025, the U.S. Food and Drug Administration granted Fast Track designation to ABBV-CLS-628, an investigational anti‑PAPP‑A monoclonal antibody developed by Calico Life Sciences in partnership with AbbVie Inc. The designation, announced today, signals the agency’s recognition of the therapy’s potential to address a serious unmet need in autosomal dominant polycystic kidney disease (ADPKD).
ABBV-CLS-628 is a novel biologic that targets the PAPP‑A protein, a key driver of kidney cyst growth. The Fast Track status expedites the review process, allowing for more frequent interactions with the FDA and potentially accelerated development timelines. The collaboration leverages Calico’s expertise in aging biology and AbbVie’s clinical development capabilities.
The designation is a strategic win for AbbVie, expanding its pipeline into a high‑prevalence, high‑cost disease area. While the therapy is still in early clinical stages, Fast Track status may shorten the path to regulatory approval and open a new revenue stream for the company in the coming years.
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