Clinical data | |
---|---|
Trade names | Rethymic |
Other names | RVT-802, [1] allogeneic processed thymus tissue-agdc |
License data | |
ATC code |
|
Legal status | |
Legal status |
Allogeneic processed thymus tissue, sold under the brand name Rethymic, is a thymus tissue medical therapy used for the treatment of children with congenital athymia. [4] It takes six months or longer to reconstitute the immune function in treated people. [4]
The most common adverse reactions include high blood pressure, cytokine release syndrome, low blood magnesium levels, rash, low platelets, and graft versus host disease. [4]
It was approved for medical use in the United States in October 2021. [4] [5] [6] Allogeneic processed thymus tissue is the first thymus tissue product approved by the U.S. Food and Drug Administration (FDA). [4]
Allogeneic processed thymus tissue is composed of human allogeneic (donor-derived) thymus tissue that is processed and cultured, and then implanted into people to help reconstitute immunity (improve immune function) in people who are athymic. [4] [7] Dosing is patient customized, determined by the surface area of the allogeneic processed thymus tissue slices and the body surface area of the patient. [4]
Allogeneic processed thymus tissue is indicated for immune reconstitution in children with congenital athymia. [2] [6]
The safety and efficacy of allogeneic processed thymus tissue were established in clinical studies that included 105 participants, with ages from one month to 16 years, who each received a single administration of allogeneic processed thymus tissue, from 1993 to 2020. [4] Allogeneic processed thymus tissue improved survival of people with congenital athymia, and most people treated with this product survived at least two years. [4]
The U.S. Food and Drug Administration (FDA) granted the application for allogeneic processed thymus tissue a rare pediatric disease voucher and granted approval of Rethymic to Enzyvant Therapeutics, Inc. [4]
This article incorporates
public domain material from the
United States Department of Health and Human Services