Biology:Allogeneic processed thymus tissue
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| Trade names | Rethymic |
| Other names | RVT-802,[1] allogeneic processed thymus tissue-agdc |
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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.
- ↑ 2.0 2.1 "Rethymic- allogenic thymocyte-depleted thymus tissue-agdc implant". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0022c28-8cda-4f1e-bcf1-1f440d37ec4a.
- ↑ "Rethymic". 29 October 2021. https://www.fda.gov/vaccines-blood-biologics/rethymic.
- ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 "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.
- ↑ 6.0 6.1 "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.
- ↑ "Current and Future Therapeutic Approaches for Thymic Stromal Cell Defects". Frontiers in Immunology 12: 655354. 2021. doi:10.3389/fimmu.2021.655354. PMID 33815417.
This article incorporates public domain material from the United States Department of Health and Human Services website http://www.fda.gov.
Further reading
- "Experience with cultured thymus tissue in 105 children". J Allergy Clin Immunol 149 (2): 747–757. August 2021. doi:10.1016/j.jaci.2021.06.028. PMID 34362576.
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