Alexion Announces Successful Phase 3 PREVENT Study of Soliris (Eculizumab) in Patients with Neuromyelitis Optica Spectrum Disorder

Alexion Pharmaceuticals (NASDAQ:ALXN) today announced positive topline results from the Phase 3 PREVENT study of Soliris (eculizumab) in patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

As quoted in the press release:

NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses. Each relapse results in stepwise accumulation of disability, including blindness and paralysis, and sometimes premature death.^1,2,3 Patients who have anti-AQP4 auto-antibodies represent approximately three quarters of all patients with NMOSD.^4,5,6,7 There are currently no approved therapies for this disease.

The study met its primary endpoint of time to first adjudicated on-trial relapse, demonstrating that treatment with Soliris^®reduced the risk of NMOSD relapse by 94.2 percent compared to placebo (p < 0.0001). At 48 weeks, 97.9 percent of patients receiving Soliris^® were free of relapse compared to 63.2 percent of patients receiving placebo. Soliris^® was generally well tolerated with a safety profile consistent with that seen in previous clinical studies and real-world use in its three approved indications. No cases of meningococcal infection were observed.

Click here to read the full press release.