What is RETHYMIC or allogeneic processed thymus tissue–agdc?
RETHYMIC is the trade name for allogeneic processed thymus tissue–agdc. It is developed by Enzyvant Therapeutics, a company of Sumitovant Biopharma. RETHYMIC is indicated for immune reconstitution in pediatric patients with congenital athymia – As per the US FDA. RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID). This is also the first thymus tissue product approved in the U.S. RETHYMIC gets its approval under the category of Cellular and Gene Therapy Products as categorized by the FDA. The entire therapy is delivered through surgical implantation of allogeneic processed thymus tissue obtained from the donors.
RETHYMIC – FDA Approved Cellular and Gene Therapy Product
LUXTURNA received its US FDA approval in December 2017. A phase III study with 31 RETHYMIC received its US FDA approval in October 2021. This approval was based on its assessment in 105 patients. The participants aged from one month to sixteen years. This data was derived from ten prospective single-arm open-label studies. The follow-up period has lasted for over twenty five long years. Rethymic improved survival of children with congenital athymia, and most children treated with this product survived at least two years. Children treated with Rethymic who survive past the first year generally survive long-term. Rethymic also reduced the frequency and severity of infections over time. RETHYMIC was granted Orphan Drug, Breakthrough Therapy, Rare Pediatric Disease designations apart from Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. More information can be found in the US FDA Press Release.
How does treatment with RETHYMIC (allogeneic processed thymus tissue–agdc)
work?
Cellular and Gene Therapies work way differently than the routine medications administered at specialty clinics and nursing homes. Most of them are not the finished drugs or medicinal solutions; they are even customized for every patient. RETHYMIC doesn’t require finer personalization. It is developed and delivered as slices of processed thymus tissue, presented in a drug product dish. Each dish would contain four slices of RETHYMIC. The dosage is finalized based on the total surface area and body surface area. It has to be administered by a team of highly qualified surgeons under controlled surgical settings. RETHYMIC should be implanted in the quadriceps muscle as per the recommended implantation procedure. Refer to the RETHYMIC Prescribing Information for more specific details.
Patients and caregivers can visit www.rethymic.com for more information and updates. The website features Enzyvant CONNECT, a support program for patients and caregivers. This is most likely applicable for the patients in US.
RETHYMIC in India – Is it possible?
Right now there is no enough clarity regarding access to RETHYMIC India. Enzyvan may not have its direct presence in India. Such companies often operate through their network and licensed partners. More information shall eventually emerge in the future.You can email us (nhs@noelgenomics.com) and express interest to receive ongoing updates. We are committed to share authentic access information. It is our endeavor to assist Indian patients seeking advanced therapies.
