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What Astellas Did Right In Using Real-World Evidence For Prograf Approval

 
• By Brenda Sandburg

US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.

victory dart
Astellas hits target with real-world evidence for Prograf indicaton • Source: Alamy

As companies increasingly seek to use real-world evidence to help gain approval of drugs, they want to know what it will take to satisfy the US Food and Drug Administration. An agency official offered insights on this in describing how Astellas Pharma, Inc.’s immunosuppressant Prograf (tacrolimus) got a lung transplant indication based on real-world data.

At a 14 September session of the Regulatory Affairs Professionals Society’s Convergence meeting, John Concato, FDA’s associate director for real-world...

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