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▎The content team editor of WuXi AppTec recently announced that the U.
S.
FDA has approved Astellas's Puleco based on real-world evidence (RWE) provided by a non-interventional study that reflects the curative effect.
Fu (tacrolimus) is used in combination with other immunosuppressive drugs to prevent organ rejection in adults and pediatric patients undergoing lung transplantation
.
PuleCoff was initially approved to prevent organ rejection in patients undergoing liver transplantation, and was later approved to prevent organ rejection in kidney and heart transplants
.
The drug is also routinely used in clinical practice for patients receiving lung transplantation
.
The FDA press release noted that this approval marks the first time an immunosuppressive drug has been approved to prevent rejection in adult and pediatric patients undergoing lung transplantation
.
This approval shows that non-interventional studies that are carefully designed based on suitable real-world data (RWD) and compared with appropriate controls can be considered by the FDA to provide adequate and good comparisons
.
Specifically, the non-interventional study supporting the approval of this new indication used the RWD of the United States Scientific Registry of Transplant Recipients (SRTR) and was supported by the Department of Health and Human Services
.
It collects data on all lung transplants in the United States, supplemented by reliable information from the Social Security Administration on mortality data
.
Compared with transplant patients without immunosuppressive therapy or with very limited immunosuppressive therapy, a significant improvement in outcome was observed in lung transplant patients who received Puracorif as part of immunosuppressive therapy
.
Image source: In addition to the RWE provided by 123RF in a non-interventional study, randomized controlled clinical trials using Puracor in other solid organ transplant settings have provided confirming evidence of effectiveness
.
Evidence from other clinical trials has been released to support the independent contribution of Pulekefu as a member of the multi-drug immunosuppressive program
.
Reference materials: [1] FDA Approves New Use of Transplant Drug Based on Real-World Evidence.
Retrieved July 16, 2021, from https:// -new-use-transplant-drug-based-real-world-evidence Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
S.
FDA has approved Astellas's Puleco based on real-world evidence (RWE) provided by a non-interventional study that reflects the curative effect.
Fu (tacrolimus) is used in combination with other immunosuppressive drugs to prevent organ rejection in adults and pediatric patients undergoing lung transplantation
.
PuleCoff was initially approved to prevent organ rejection in patients undergoing liver transplantation, and was later approved to prevent organ rejection in kidney and heart transplants
.
The drug is also routinely used in clinical practice for patients receiving lung transplantation
.
The FDA press release noted that this approval marks the first time an immunosuppressive drug has been approved to prevent rejection in adult and pediatric patients undergoing lung transplantation
.
This approval shows that non-interventional studies that are carefully designed based on suitable real-world data (RWD) and compared with appropriate controls can be considered by the FDA to provide adequate and good comparisons
.
Specifically, the non-interventional study supporting the approval of this new indication used the RWD of the United States Scientific Registry of Transplant Recipients (SRTR) and was supported by the Department of Health and Human Services
.
It collects data on all lung transplants in the United States, supplemented by reliable information from the Social Security Administration on mortality data
.
Compared with transplant patients without immunosuppressive therapy or with very limited immunosuppressive therapy, a significant improvement in outcome was observed in lung transplant patients who received Puracorif as part of immunosuppressive therapy
.
Image source: In addition to the RWE provided by 123RF in a non-interventional study, randomized controlled clinical trials using Puracor in other solid organ transplant settings have provided confirming evidence of effectiveness
.
Evidence from other clinical trials has been released to support the independent contribution of Pulekefu as a member of the multi-drug immunosuppressive program
.
Reference materials: [1] FDA Approves New Use of Transplant Drug Based on Real-World Evidence.
Retrieved July 16, 2021, from https:// -new-use-transplant-drug-based-real-world-evidence Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
