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Alexion’s Soliris Slips Up In Pivotal PROTECT Kidney Transplant Study

 
• By Alexandra Shimmings

A difficult December for Alexion sees a pivotal study of its blockbuster Soliris failing to show any benefit in preventing delayed graft function in kidney transplant patients, an indication for which there are no approved treatments.

Kidneys
• Source: Shutterstock

Alexion Pharmaceuticals Inc. has been left disappointed by top-line data from the Phase II/III registration trial for its first-in-class terminal complement inhibitor Soliris (eculizumab) in preventing delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney.

If successful, the study could have paved the way for approval in another indication for Alexion’s mainstay and multibillion-dollar selling...

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