Treats paroxysmal nocturnal hemoglobinuria (PNH). BLA 125166, held by Alexion Pharm. Eculizumab.
As of Nov 14, 2026, BLA 125166 (Soliris), held by Alexion Pharm, was first approved by FDA on Mar 16, 2007, with 27 approved supplements and 0 published complete response letters.
SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive.
| Feb 28, 2025 | Supplement 448Efficacy (new indication or use) · Priority review | Approved | |
| Jun 27, 2019 | Supplement 431Efficacy (new indication or use) · Priority review | Approved | |
| Oct 23, 2017 | Supplement 422Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 2014 | Supplement 368Efficacy (new indication or use) · Standard review | Approved | |
| Sep 23, 2011 | Supplement 172Efficacy (new indication or use) · Priority review | Approved | |
| Mar 16, 2007 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Soliris300MG · injectable; iv (infusion) | Eculizumab | Rx |
| Oct 21, 2026 | Supplement 455REMS | Approved | |
| Jun 30, 2026 | Supplement 454Labeling · Standard review | Approved | |
| Jun 1, 2026 | Supplement 453REMS | Approved | |
| Jun 27, 2025 | Supplement 450REMS | Approved | |
| Feb 28, 2025 | Supplement 448Efficacy (new indication or use) · Priority review | Approved | |
| Sep 19, 2024 | Supplement 447Labeling · Standard review | Approved | |
| Jun 28, 2024 | Supplement 445Labeling · Standard review | Approved | |
| Mar 22, 2024 | Supplement 443REMS | Approved | |
| Feb 8, 2024 | Supplement 446Labeling · Standard review | Approved | |
| Nov 20, 2020 | Supplement 434Labeling · Standard review | Approved | |
| Apr 7, 2020 | Supplement 432REMS | Approved | |
| Jun 27, 2019 | Supplement 431Efficacy (new indication or use) · Priority review | Approved | |
| Jul 25, 2018 | Supplement 428REMS | Approved | |
| Jul 25, 2018 | Supplement 427Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 426Labeling · Standard review | Approved | |
| Oct 23, 2017 | Supplement 422Efficacy (new indication or use) · Standard review | Approved | |
| Jan 13, 2017 | Supplement 417Labeling · Standard review | Approved | |
| Apr 13, 2016 | Supplement 414REMS | Approved | |
| Dec 3, 2015 | Supplement 413REMS | Approved | |
| Dec 3, 2015 | Supplement 412Labeling · Standard review | Approved | |
| Oct 10, 2014 | Supplement 409REMS | Approved | |
| Apr 30, 2014 | Supplement 380Labeling · Standard review | Approved | |
| Apr 30, 2014 | Supplement 368Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2012 | Supplement 273Labeling · Standard review | Approved | |
| Sep 23, 2011 | Supplement 172Efficacy (new indication or use) · Priority review | Approved | |
| Jun 4, 2010 | Supplement 44Labeling · Standard review | Approved | |
| Jun 30, 2009 | Supplement 33Labeling · Standard review | Approved | |
| Mar 16, 2007 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
