Allogeneic processed thymus tissue

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]

Allogeneic processed thymus tissue

Clinical data
Trade names	Rethymic
Other names	RVT-802,[1] allogeneic processed thymus tissue-agdc
License data	US DailyMed: Allogeneic_processed_thymus_tissue
ATC code	None
Legal status
Legal status	US: ℞-only[2][3][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]

Medical uses

Allogeneic processed thymus tissue is indicated for immune reconstitution in children with congenital athymia.^[2][6]

History

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]