FDA Expands Indication for PROGRAF® for Lung Transplant Recipients

Astellas Pharma Inc. announced that the U.S. FDA approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.

"We are pleased with this FDA approval and the Agency's continued recognition of PROGRAF, which was first approved for liver transplant recipients nearly three decades ago," said Salim Mujais, Senior Vice President, Therapeutic Area Head, Medical Specialties, Astellas. "The current approval expands the indications for PROGRAF from liver, kidney and heart transplants to adult and pediatric patients who receive a lung transplant in combination with other medicines to help prevent organ rejection."

Based on 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.