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# FDA Priority Review for Ultomiris sBLA
- URL: https://www.fdaweb.com/fda-priority-review-for-ultomiris-sbla/
- Published: 2019-06-20T12:00:00.000Z
- Updated: 2026-09-15T01:33:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144387

FDA has accepted for priority review an Alexion Pharmacuticals’ supplemental BLA for Ultomiris (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, for use in treating people with atypical hemolytic uremic syndrome (HUS) in order to inhibit complement-mediated thrombotic microangiopathy (TMA). Atypical HUS is a severe and chronic ultra-rare disease that can cause progressive damage to vital organs, like the kidneys which can lead to kidney failure and premature death. The agency has set a review action target date of 10/19.

The submission is based on [previously announced results](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fnews.alexion.com%2Fpress-release%2Fproduct-news%2Falexion-announces-positive-top-line-results-phase-3-study-ultomiris-ravul&esheet=52002482&newsitemid=20190620005331&lan=en-US&anchor=previously+announced+results&index=2&md5=d66811269229e6c6f860beb9ccde286c&ref=fdaweb.com) from the Phase 3 study of Ultomiris in people with atypical HUS, which met the primary endpoint of complete TMA response, defined by hematologic normalization and improved kidney function. The monoclonal antibody is currently approved for treating adults with a disease called paroxysmal nocturnal hemoglobinuria.