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Rethymic FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 4, 2021.

FDA Approved: Yes (First approved October 8, 2021)
Brand name: Rethymic
Generic name: allogeneic processed thymus tissue-agdc
Dosage form: for Surgical Implantation
Company: Enzyvant Therapeutics, Inc.
Treatment for: Congenital Athymia

Rethymic (allogeneic processed thymus tissue-agdc) is a one-time regenerative tissue-based therapy indicated for immune reconstitution in pediatric patients with congenital athymia.

  • Congenital athymia is an ultra-rare condition in which children are born without a thymus, causing profound immunodeficiency, vulnerability to potentially fatal infections, and life-threatening immune dysregulation.
  • Rethymic is engineered human thymus tissue designed to regenerate the thymic function in children with congenital athymia. It consists of yellow to brown slices of processed tissue with varying thickness and shape.
  • Rethymic is surgically implanted into the quadriceps muscle during a single session at a qualified hospital. The dosage is determined by the total surface area of the Rethymic slices and the recipient's body surface area (BSA).
  • Common adverse reactions include hypertension, cytokine release syndrome, rash, hypomagnesemia, renal impairment / failure, thrombocytopenia, and graft versus host disease.

Development timeline for Rethymic

Oct  8, 2021Approval FDA Approves Rethymic (allogeneic processed thymus tissue-agdc) One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

Further information

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