FDA Gives Fast Track Designation to Anemia Treatment for NDD-CKD Patients

The US Food and Drug Administration (FDA) has granted Fast Track designation to DISC-0974 for the treatment of anemia in patients with nondialysis-dependent chronic kidney disease (NDD-CKD). DISC-0974 is an investigational monoclonal antibody against hemojuvelin, a bone morphogenetic protein-signaling coreceptor; it is intended to suppress hepcidin production and increase serum iron levels in patients with anemia or inflammation.

“Receiving Fast Track designation highlights the unmet need for the millions of NDD-CKD patients with anemia, as well as the potential of DISC-0974 to address this need,” said John Quisel, JD, PhD, president and CEO of Disc Medicine, which in-licensed the drug from AbbVie in 2019. “We believe DISC-0974 could be a transformative therapy for these patients and are excited to share additional results from our ongoing phase 1b/2 study in NDD-CKD patients with anemia this year.” That study (NCT05745883) is currently assessing the safety, tolerability, and efficacy of DISC-0974.

The Fast Track process allows the FDA to facilitate the development and expedite the review of investigational drugs intended to treat serious conditions and for which nonclinical or clinical data demonstrate the potential to address unmet medical need.