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Alexion Says Clinical, Statistical Improvement in 2nd Endpoints of Eculizumab Study

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UPDATE: 8-K from Alexion Pharma Shows FDA Issued Form 483 at Aug. Inspection of Site, Does Not Expect Material Financial Effect Related to FDA Concern
Alexion Initiates Multinational Registration Trial of Eculizumab for Prevention of DGF after Kidney Transplantation

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that researchers have presented data from a single-arm, open-label, investigator-initiated Phase 2 study of eculizumab (Soliris^®) as an investigational therapy in 14 patients with severe, relapsing neuromyelitis optica (NMO), a life-threatening, ultra-rare neurological disorder. The study met its primary efficacy endpoint with high degrees of clinical and statistical significance. Clinically and statistically significant improvements were also observed in key secondary endpoints. Data were presented today at a Scientific Symposium Oral Session at the American Neurological Association annual meeting in Boston, Mass.^1

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