Allogeneic processed thymus tissue

Allogeneic processed thymus tissue
Clinical data
Trade namesRethymic
Other namesRVT-802,[1] allogeneic processed thymus tissue-agdc
License data
ATC code
  • None
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

  1. ↑ "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. 1 2 "Rethymic- allogenic thymocyte-depleted thymus tissue-agdc implant". DailyMed. Retrieved 20 December 2021.
  3. ↑ "Rethymic". U.S. Food and Drug Administration. 29 October 2021. STN: 125685. Retrieved 31 October 2021.
  4. 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. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ "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. 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.
  7. ↑ 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.

Public Domain This article incorporates public domain material from the United States Department of Health and Human Services website http://www.fda.gov.

Further reading


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