Enzyvant receives FDA approval for tissue-based therapy

The US Food and Drug Administration (FDA) has approved Rethymic (allogeneic processed thymus tissue‐agdc), a one‐time regenerative tissue‐based therapy for immune reconstitution in pediatric patients with congenital athymia.

Rethymic has been developed by Enzyvant, a subsidiary of Sumitovant Biopharma that is itself wholly‐owned by Japanese drugmaker Sumitomo Dainippon Pharma (TYO: 4506).

"For too long, families have faced a reality that the brutal journey for pediatric congenital athymia patients receiving supportive care only would end tragically"Rachelle Jacques, chief executive of Enzyvant, said: “For too long, families have faced a reality that the brutal journey for pediatric congenital athymia patients receiving supportive care only would end tragically. The FDA approval of Rethymic will help patients access this desperately needed therapy beyond clinical study.”