Health
Calico Life Sciences Announces U.S. FDA Orphan Drug Designation for Investigational Treatment of Autosomal Dominant Polycystic Kidney Disease
Calico Life Sciences LLC (Calico), a biotechnology organization focused on aging and age-related diseases and founded by Alphabet Inc. and Arthur D. Levinson, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). ABBV-CLS-628, an anti-PAPP-A monoclonal antibody, was developed by Calico in collaboration with AbbVie Inc. The the
About this update from Abbvie Inc.
[{"type":"text","content":"SAN FRANCISCO, Nov. 5, 2025 /PRNewswire/ -- Calico Life Sciences LLC (Calico), a biotechnology organization focused on aging and age-related diseases and founded by Alphabet Inc. and Arthur D. Levinson, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). ABBV-CLS-628, an anti-PAPP-A monoclonal antibody, was developed by Calico in collaboration with AbbVie Inc. The therapy was recently granted Fast Track Designation by the FDA and is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with ADPKD.","length":707,"tagName":"p"},{"type":"image","alt":"Calico Logo (PRNewsfoto/Calico)","displaySize":"","headline":null,"caption":"Calico Logo (PRNewsfoto/Calico)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":102,"url":"https://media.zenfs.com/en/prnewswire.com/8051c43e99bd5e245c790803d85fe028"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/fUaSa2BcgloFvEuB10ULFg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE4MDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/8051c43e99bd5e245c790803d85fe028","width":400,"height":102}},"href":"https://mma.prnewswire.com/media/2063086/Calico_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""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," said Arthur D. Levinson, Ph.D., CEO of Calico. "People living with this disease face a high risk of rapid disease progression and we will continue to advance this program with the goal of improving the treatment trajectory for patients."","length":414,"tagName":"p"},{"type":"text","content":"ADPKD is the most common inherited kidney disease worldwide.1 Characterized by the development and growth of fluid-filled cysts in both kidneys, the progressive disease leads to kidney failure in more than 50% of patients by age 60. At that stage, dialysis or a transplant are the only treatment options.2 ","length":305,"tagName":"p"},{"type":"text","content":"The ODD was created under the Orphan Drug Act, a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare...