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]
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| Trade names | Rethymic |
| Other names | RVT-802,[1] allogeneic processed thymus tissue-agdc |
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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 edit
Allogeneic processed thymus tissue is indicated for immune reconstitution in children with congenital athymia.[2][6]
History edit
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]
References edit
- ^ "Enzyvant Resubmits Biologics Licensing Application (BLA) to FDA for RVT-802 for Pediatric Congenital Athymia" (Press release). Enzyvant. 27 April 2021. Retrieved 8 October 2021 – via GlobeNewswire.
- ^ a b "Rethymic- allogenic thymocyte-depleted thymus tissue-agdc implant". DailyMed. Retrieved 20 December 2021.
- ^ "Rethymic". U.S. Food and Drug Administration. 29 October 2021. STN: 125685. Retrieved 31 October 2021.
- ^ a b c d e f g h i j k "FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia". U.S. Food and Drug Administration (FDA) (Press release). 8 October 2021. Retrieved 8 October 2021. This article incorporates text from this source, which is in the public domain.
- ^ "Enzyvant Receives FDA Approval for Rethymic (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia" (Press release). Enzyvant. 8 October 2021. Retrieved 8 October 2021 – via GlobeNewswire.
- ^ a b "Enzyvant Receives FDA Approval for Rethymic (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia". Enzyvant (Press release). 8 October 2021. Retrieved 8 October 2021.
- ^ Kreins AY, Bonfanti P, Davies EG (2021). "Current and Future Therapeutic Approaches for Thymic Stromal Cell Defects". Frontiers in Immunology. 12: 655354. doi:10.3389/fimmu.2021.655354. PMC 8012524. PMID 33815417.
This article incorporates public domain material from the United States Department of Health and Human Services