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▎ WuXi AppTec content team editor October 8, 2021, Takeda announced that the US FDA Antimicrobial Drug Advisory Committee (AMDAC) unanimously supported its research drug maribavir (TAK-620) for treatment of hematopoietic stem cell transplantation (HSCT) Or refractory cytomegalovirus (CMV) infection in adult patients after solid organ transplantation (SOT)
.
The press release stated that if approved by the FDA, maribavir will become the first approved therapy to treat this patient population
.
CMV is a beta herpes virus that can infect humans.
It is one of the most common infections in transplant patients.
It is estimated that the incidence in solid organ transplant patients is about 16-56%, and the incidence in hematopoietic stem cell transplant patients is about It is 30-70%
.
It increases the risk of disease for patients undergoing transplantation, and may also increase the risk of transplant rejection and opportunistic co-infection
.
The current approved therapies not only have serious side effects, but CMV has developed resistance to them
.
Maribavir is a UL97 protein kinase inhibitor.
It has an innovative mechanism to inhibit CMV virus replication and has higher safety than existing therapies
.
The US FDA has granted maribavir breakthrough therapy designation for the treatment of CMV infections and diseases in transplant patients who are resistant or refractory to previous therapies
.
In May of this year, the FDA granted priority review qualification for maribavir
.
"Today's vote for our antiviral drugs under development marks an important step for us to provide the first approved therapy for this patient group.
.
"Takeda vice president and maribavir global project leader Dr.
Obi Umeh said, "We look forward to cooperating with the FDA in the future
.
"Reference: [1] FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance.
Retrieved October 8, 2021, from https:// with-Cytomegalovirus-CMV-Infection- and-Disease-Refractory-to-Treatment-with-or-Without-Resistance Disclaimer: WuXi content team biomedical progress of global health research focused presentation
.
This article is only for information purposes, The opinions
in
this article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes 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 if approved by the FDA, maribavir will become the first approved therapy to treat this patient population
.
CMV is a beta herpes virus that can infect humans.
It is one of the most common infections in transplant patients.
It is estimated that the incidence in solid organ transplant patients is about 16-56%, and the incidence in hematopoietic stem cell transplant patients is about It is 30-70%
.
It increases the risk of disease for patients undergoing transplantation, and may also increase the risk of transplant rejection and opportunistic co-infection
.
The current approved therapies not only have serious side effects, but CMV has developed resistance to them
.
Maribavir is a UL97 protein kinase inhibitor.
It has an innovative mechanism to inhibit CMV virus replication and has higher safety than existing therapies
.
The US FDA has granted maribavir breakthrough therapy designation for the treatment of CMV infections and diseases in transplant patients who are resistant or refractory to previous therapies
.
In May of this year, the FDA granted priority review qualification for maribavir
.
"Today's vote for our antiviral drugs under development marks an important step for us to provide the first approved therapy for this patient group.
.
"Takeda vice president and maribavir global project leader Dr.
Obi Umeh said, "We look forward to cooperating with the FDA in the future
.
"Reference: [1] FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance.
Retrieved October 8, 2021, from https:// with-Cytomegalovirus-CMV-Infection- and-Disease-Refractory-to-Treatment-with-or-Without-Resistance Disclaimer: WuXi content team biomedical progress of global health research focused presentation
.
This article is only for information purposes, The opinions
in
this article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes 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
.