AbbVie (ABBV) Kidney Disease Therapy Garners FDA Fast Track

 

• AbbVie (ABBV, Financial) has received Fast Track Designation from the U.S. FDA for its kidney disease treatment, ABBV-CLS-628, in collaboration with Calico Life Sciences.
• The treatment targets autosomal dominant polycystic kidney disease (ADPKD) and is currently in Phase 2 trials across 95 international sites.
• Fast Track status facilitates an accelerated development and review process, potentially expediting the drug's market entry.

Calico Life Sciences, in collaboration with AbbVie (ABBV), has secured Fast Track Designation from the U.S. FDA for their kidney disease treatment, ABBV-CLS-628. This therapy targets autosomal dominant polycystic kidney disease (ADPKD), a genetically linked condition responsible for kidney cysts and potential failure. Currently, ABBV-CLS-628 is in a Phase 2 trial, actively engaging around 95 international sites. 

https://www.gurufocus.com/news/3129360/abbvie-abbv-kidney-disease-therapy-garners-fda-fast-track-status