FDA grants fast track designation to neihulizumab for acute GVHD
Click Here to Manage Email Alerts
The FDA granted fast track designation to neihulizumab for treatment of steroid-refractory acute graft-versus-host disease, according to the agent’s manufacturer.
Neihulizumab (AltruBio) is an immune checkpoint regulator that targets PSGL-1. It is designed to trigger the depletion of chronically activated T cells.
The agent is being evaluated in an investigator-sponsored study as front-line treatment for acute GVHD, as well as a company-sponsored phase 1b trial of patients with steroid-refractory acute GVHD.
“Receiving fast track designation for neihulizumab in steroid-refractory acute GVHD is another important regulatory milestone for this clinical program,” Judy Chou, PhD, president and CEO of AltruBio, said in a company-issued press release. “This designation validates the fact that, although there are treatment options for this condition, significant unmet medical need remains. We believe neihulizumab has the potential to make a meaningful impact on the clinical outcome of patients, and we look forward to working closely with the FDA to further demonstrate this in our ongoing clinical trials.”
The FDA previously granted orphan drug designation to neihulizumab.
Click Here to Manage Email Alerts