| Clinical data | |
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| Trade names | Rethymic |
| Other names | RVT-802,[1] allogeneic processed thymus tissue-agdc |
| License data | |
| ATC code |
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| 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]
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]
References
- ↑ "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.
- 1 2 "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.
- 1 2 3 4 5 6 7 8 9 10 11 "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.
- 1 2 "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
Further reading
- Markert ML, Gupton SE, McCarthy EA (August 2021). "Experience with cultured thymus tissue in 105 children". J Allergy Clin Immunol. 149 (2): 747–757. doi:10.1016/j.jaci.2021.06.028. PMC 8810898. PMID 34362576.