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USFDA approves new use of transplant drug based on real-world evidence 

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Marks first immunosuppressant drug approved to prevent rejection in adults and paediatric patients who receive lung transplants
The US Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. The agency approved Prograf for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and paediatric patients receiving lung transplantation. Approval was granted to Astellas Pharma US, Inc.

Prograf, originally approved to prevent organ rejection in patients receiving liver transplants, was later approved to prevent organ rejection for kidney and heart transplants as well. The drug has also been routinely used in clinical practice for patients receiving lung transplants. As per a note from the agency, this approval marks the first approval of an immunosuppressant drug to prevent rejection in adults and paediatric patients who receive lung transplants. Prograf is the only approved immunosuppressant drug product for this population.

The non-interventional study supporting approval for this new indication used real-world data (RWD) from the US Scientific Registry of Transplant Recipients (SRTR), supported by the Department of Health and Human Services. As per the agency release, the data were collected on all lung transplants in the US and were supplemented by information from the Social Security Administration’s Death Master File as a trusted repository of mortality data. A dramatic improvement in outcomes was observed among lung transplant patients receiving Prograf as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy.

In addition to the RWE from the non-interventional study, randomised controlled trials of Prograf used in other solid organ transplant settings provided confirmatory evidence of effectiveness. Additional clinical trial evidence from research publications supports the independent contribution of Prograf as part of a multidrug immunosuppressive regimen.

The release cautions that Prograf should only be prescribed by physicians experienced in immunosuppressive therapy and management of organ transplant and patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Prograf is associated with increased risk of developing lymphoma and other malignancies and is associated with increased susceptibility to bacterial, viral, fungal, and protozoal, including opportunistic infections.

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