Treats acute attacks of hereditary angioedema (HAE). BLA 125277, held by Dyax Corp.. Ecallantide.
As of Nov 13, 2026, BLA 125277 (Kalbitor), held by Dyax Corp., was first approved by FDA on Dec 1, 2009, with 7 approved supplements and 0 published complete response letters.
KALBITOR (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2014 | Supplement 70Efficacy (new indication or use) · Priority review | Approved | |
| Dec 1, 2009 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kalbitor10MG/ML · injectable; injection | Ecallantide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2020 | Supplement 81Labeling · Standard review | Approved | |
| Sep 8, 2014 | Supplement 71Labeling · Standard review | Approved | |
| Mar 28, 2014 | Supplement 70Efficacy (new indication or use) · Priority review | Approved | |
| Apr 10, 2013 | Supplement 65Labeling · Standard review | Approved | |
| Apr 24, 2012 | Supplement 50Labeling · Standard review | Approved | |
| Aug 17, 2011 | Supplement 37Labeling · Standard review | Approved | |
| Apr 5, 2011 | Supplement 32Labeling · Standard review | Approved | |
| Dec 1, 2009 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
