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 product in an area of huge unmet medical need: there are no therapies licensed to
The failure adds to a difficult end of year for Alexion, which has just lost its CEO David Hallal and CFO Vikas Sinha amid an audit investigation and a delay to its 10-Q filing. (Also see "Alexion Hunts For A CEO While Investors Await Investigation Details" - Scrip, 13 December, 2016