Kadmon Holdings Inc. said it received the U.S. Food and Drug Administration's breakthrough therapy designation for KD025 to treat stem cell transplant complication.
Chronic graft-versus-host disease is a common and often fatal complication following stem cell transplantation in which transplanted immune cells attack the patient's cells, leading to inflammation and damage to various organs.
The designation is based on a phase 2 study, which showed that the drug was well-tolerated and demonstrated clinical activity among the patients with the complication.
New York-based Kadmon is recruiting patients for another midstage study, named KD025-213, for adults with chronic graft-versus-host disease who have received at least two prior lines of systemic therapy.
The FDA's breakthrough therapy designation accelerates the development and review of drugs that are meant to treat a serious condition and have shown a meaningful benefit.