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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.

References

  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. https://ir.alpineimmunesciences.com/index.php/news-releases/news-release-details/alpine-immune-sciences-alpn-101-receives-fda-orphan-drug. 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. https://bit.ly/2WiRktX?rel=0. Accessed May 24, 2019.
  3. FDA approves treatment for chronic graft versus host disease. Published August 2, 2017. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-chronic-graft-versus-host-disease. Accessed March 18, 2020.

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