Astellas Pharma’s Transplant Drug Wins New FDA Approval

The FDA has approved Astellas Pharma’s Prograf (tacrolimus) for use in combination with other immunosuppressants to prevent organ rejection in lung transplant patients.

The approval was supported by real-world evidence of effectiveness as well as confirmatory clinical trials, the agency said.

Prograf, which is the first FDA-approved immunosuppressant for this treatment group, was previously cleared to prevent organ rejection in liver, kidney and heart transplant patients.