Rare Events, Rare Disease: "Theoretical" Issues Central To Soliris Review
This article was originally published in Pharmaceutical Approvals Monthly
The effect of Alexion’s paroxysmal nocturnal hemoglobinuria therapy Soliris (eculizumab) on thrombosis, a major clinical problem associated with the rare blood disorder, was one of the most contested issues in the review of the Soliris BLA, FDA review documents suggest.
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