Policy & Regulation
Calico Life Sciences' ABBV-CLS-628S granted US FDA Orphan Drug Designation
6 November 2025 -

Calico Life Sciences LLC, a biotechnology company focused on ageing and age-related diseases, founded by Alphabet Inc (NASDAQ:GOOG) and Arthur D. Levinson, announced on Wednesday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

The product is an anti-PAPP-A monoclonal antibody that was developed by Calico in collaboration with AbbVie Inc (NYSE:ABBV).

ABBV-CLS-628 was recently granted Fast Track Designation by the FDA and is currently in a Phase 2 clinical trial assessing its safety and efficacy in patients with ADPKD.

Arthur D Levinson, PhD, Calico CEO, said: "We are pleased that ABBV-CLS-628 has received both Fast Track and Orphan Drug designations, underscoring the urgent unmet need facing the ADPKD community. People living with this disease face a high risk of rapid disease progression and we will continue to advance this programme with the goal of improving the treatment trajectory for patients."

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