News >

FDA Grants ALPN-101 Orphan Drug Designations in GVHD

Jason M. Broderick @jasoncology
Published: Wednesday, Mar 18, 2020

The FDA has granted 2 Orphan Drug Designations to ALPN-101 for the prevention and treatment of acute graft-versus-host-disease (GVHD), according to Alpine Immune Sciences, Inc., the company developing the first-in-class selective dual T cell costimulation inhibitor.1

Twenty-one percent of responders had a CR and 45% had a partial response. Additionally, most responders were able to reduce steroid doses to an acceptable minimal level.


  1. Alpine Immune Sciences’ ALPN-101 Receives FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease. Published online March 18, 2020. Accessed March 18, 2020.
  2. FDA Approves Jakafi (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease. Incyte. Published May 24, 2019. Accessed May 24, 2019.
  3. FDA approves treatment for chronic graft versus host disease. Published August 2, 2017. Accessed March 18, 2020.

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication