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▎The content team editor of WuXi AppTec today, the US FDA announced that it has approved the marketing of Rethymic, a thymus tissue therapy, for the treatment of congenital athymia in children, which is a rare immune disease
.
The press release stated that this is the first thymus tissue product approved by the US FDA
.
Congenital athymia is a rare immune disease
.
A child is born without a thymus, which plays an important role in the body's fight against infection
.
Children with this disease usually die within two years and often suffer from life-threatening infections due to lack of normal T cells
.
Rethymic is composed of allogeneic thymus tissue obtained from a donor.
After processing and culture, it is transplanted into the patient's body to help rebuild immunity
.
The safety and efficacy of Rethymic are supported by clinical studies involving 105 children (aged from 1 month to 16 years)
.
It improves the survival of children with congenital athymia, and most children who receive treatment survive for at least two years
.
Children who survive the first year after receiving a Rethymic transplant usually survive long-term
.
It also reduces the frequency and severity of infections
.
The most common adverse reactions are hypertension, cytokine release syndrome, low blood magnesium levels, rash, low platelets and graft-versus-host disease
.
"Today's approval marks the first FDA-approved therapy for the treatment of children with this rare disease
.
"Doctor Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, said, "We are committed to developing safe and effective medical products for patients with rare diseases.
This is an area with a wide range of unmet needs
.
"Reference: [1] FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia.
Retrieved October 8, 2021, from https:// -pediatric-patients-congenital-athymia disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views in the article do not represent WuXi AppTec's position, nor does it represent WuXi AppTec's support or I oppose the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
.
The press release stated that this is the first thymus tissue product approved by the US FDA
.
Congenital athymia is a rare immune disease
.
A child is born without a thymus, which plays an important role in the body's fight against infection
.
Children with this disease usually die within two years and often suffer from life-threatening infections due to lack of normal T cells
.
Rethymic is composed of allogeneic thymus tissue obtained from a donor.
After processing and culture, it is transplanted into the patient's body to help rebuild immunity
.
The safety and efficacy of Rethymic are supported by clinical studies involving 105 children (aged from 1 month to 16 years)
.
It improves the survival of children with congenital athymia, and most children who receive treatment survive for at least two years
.
Children who survive the first year after receiving a Rethymic transplant usually survive long-term
.
It also reduces the frequency and severity of infections
.
The most common adverse reactions are hypertension, cytokine release syndrome, low blood magnesium levels, rash, low platelets and graft-versus-host disease
.
"Today's approval marks the first FDA-approved therapy for the treatment of children with this rare disease
.
"Doctor Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, said, "We are committed to developing safe and effective medical products for patients with rare diseases.
This is an area with a wide range of unmet needs
.
"Reference: [1] FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia.
Retrieved October 8, 2021, from https:// -pediatric-patients-congenital-athymia disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views in the article do not represent WuXi AppTec's position, nor does it represent WuXi AppTec's support or I oppose the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
