Families Are Reeling after FDA Rejects Therapy for Kids Born Without a Thymus Gland

December 6, 2019

(STAT News) – All that was supposed to change on Wednesday, when the Food and Drug Administration had to decide whether it was approving a tissue implant that can dramatically increase such children’s chances of survival. Since 1993, 101 children have gotten the experimental treatment at Duke University Hospital, and 73 of them are still alive. With numbers like that, the approval seemed like a shoe-in, almost a formality. As soon as the positive decision was announced, the Luckesens were told, they’d get a call about scheduling Charlie’s surgery. On Wednesday, Katie Luckesen checked her phone again and again — while snuggling with her daughter, while helping the kids with schoolwork, while making stovetop Christmas toffee — but the good news never came. Only the next morning did she learn that regulators had rejected the application.