Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients. The sNDA submission was based on Real World Evidence (RWE) generated from a retrospective observational study of data from the U.S. Scientific Registry of Transplant Recipients (SRTR), which captures data on all transplants performed in the U.S. The study analyzed outcomes based on discharge immunosuppression treatment regimens in recipients of a primary lung transplant between 1999 and 2017 who were alive at the time of discharge. In adult (n=15,478) and pediatric (n=450) patients receiving tacrolimus immediate-release (IR) products in combination with mycophenolate mofetil (MMF), the one-year graft survival estimates from time of discharge were 90.9% (adult) and 91.7% (pediatric). In adult (n=4,263) and pediatric (n=72) patients receiving tacrolimus IR in combination with azathioprine (AZA), the one-year graft survival estimates from time of discharge were 90.8% (adult) and 84.7% (pediatric). The number of lung transplants performed annually increased from 724 in 1999 to 2,248 in 2017, and in recent years, over 85.5% of lung transplant recipients are treated with tacrolimus, MMF and steroids. Based on the SRTR study results, published clinical trials and postmarketing reports, the safety profile for lung transplant patients treated with PROGRAF is consistent with the safety profile in liver, kidney and heart transplant patients treated with PROGRAF. The primary adverse reactions described include renal dysfunction, infection, diabetes, gastrointestinal disturbances (e.g., diarrhea), hypertension, and neurological events (e.g., tremor). As expected, lung transplant patients have a higher incidence of pulmonary complications (e.g., pneumonia, bronchiolitis obliterans syndrome) than other solid organ transplant patients, which is in part due to the underlying disease and to the nature of the transplanted organ. The FDA granted Orphan Drug Designation (ODD) to PROGRAF for the prevention of rejection after lung transplant in September 2019. PROGRAF, which was discovered and developed by Astellas, is currently marketed in approximately 100 countries/areas and has greatly contributed to medical transplantation globally as a first-line immunosuppressant for organ transplantation. PROGRAF® was initially approved by the FDA in 1994. PROGRAF® is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart or lung transplants, in combination with other immunosuppressants.