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# Transplant Drug Gets Orphan/Fast Track Status
- URL: https://www.fdaweb.com/transplant-drug-gets-orphan-fast-track-status/
- Published: 2024-08-20T12:00:00.000Z
- Updated: 2026-09-14T14:38:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157618

FDA has granted ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients with steroid-refractory acute graft-versus-host disease (aGvHD). The serious and often fatal complication occurs after hematopoietic stem cell transplantation when the donor's immune cells attack the recipient's tissues, according to the company.

RLS-0071 is designed to modulate the complement and innate inflammatory pathways, ReAlta says. The therapy is currently being evaluated in a Phase 2, open label clinical trial in hospitalized patients with steroid-refractory aGvHD ([NCT06343792](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06343792&esheet=54110716&newsitemid=20240819089603&lan=en-US&anchor=NCT06343792&index=1&md5=d5ade6547204683a098477d531c04d86&ref=fdaweb.com)).