FDA grants fast track designation for neihulizumab in steroid refractory aGvHD

On March 08, 2021, the U.S. Food and Drug Administration (FDA) granted fast track designation for neihulizumab in steroid refractory acute graft-versus-host disease (aGvHD).¹

Neihulizumab is an immune checkpoint regulator targeting PSGL-1/CD162, thereby inducing apoptosis in chronically activated T cells. The drug is under investigation in a phase Ib multi-dose trial (NCT03327857) in steroid refractory aGVHD, as presented during the 25th European Hematology Association (EHA) Annual Congress. Preliminary results showed that neihulizumab (at either 3 mg/kg or 6 mg/kg) was well tolerated with promising efficacy signal in patients with any grade steroid refractory aGVHD involving the skin, with or without other organ involvement.²

Neihulizumab is also studied for front line treatment of aGVHD (NCT04144036) and has already received orphan drug designation by the FDA for the treatment of aGVHD.¹