Phase III PREVENT study of Soliris in neuromyelitis optica spectrum disorder published in NEJM

Alexion Pharmaceuticals announced that the New England Journal of Medicine (NEJM) published positive data from the Phase III PREVENT study of Soliris (eculizumab), a first-in-class complement inhibitor, in adult patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD). There is currently no approved therapy for patients with NMOSD. As announced previously, 97.9 percent of patients receiving Soliris were relapse-free at 48 weeks compared with 63.2 percent of patients receiving placebo. New data published in NEJM and to be presented for the first time at the AAN meeting confirm that the significant relapse reduction observed in the PREVENT study was sustained through three years of treatment. All patients receiving Soliris monotherapy and the vast majority of patients receiving Soliris in addition to immunosuppressive therapy (IST) were relapse-free.

The safety profile of Soliris was consistent with that seen in other clinical studies. As announced previously, 97.9 percent of patients receiving Soliris were relapse-free at 48 weeks compared with 63.2 percent of patients receiving placebo. New data published in NEJM and to be presented for the first time at the AAN meeting confirm that the significant relapse reduction observed in the PREVENT study was sustained through three years of treatment. All patients receiving Soliris monotherapy and the vast majority of patients receiving Soliris in addition to immunosuppressive therapy (IST) were relapse-free. The safety profile of Soliris was consistent with that seen in other clinical studies. The NEJM online publication coincides with the American Academy of Neurology (AAN) Annual Meeting, May 4-10, 2019 in Philadelphia, where these data will also be presented in the Emerging Science session.

See: "Eculizumab in Aquaporin-4–Positive Neuromyelitis Optica Spectrum Disorder" Sean J. Pittock et al. NEJM May 3, 2019 DOI: 10.1056/NEJMoa1900866