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Kalbitor Approval History

FDA Approved: Yes (First approved December 1, 2009)
Brand name: Kalbitor
Generic name: ecallantide
Dosage form: Injection
Previous Name: DX-88
Company: Dyax Corp.
Treatment for: Angioedema

Kalbitor (ecallantide) is plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

Development History and FDA Approval Process for Kalbitor

DateArticle
Apr  7, 2014Approval FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older
Dec  2, 2009Approval Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
Jun  8, 2009Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema
Mar 27, 2009Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema
Feb  5, 2009FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema
Jan 13, 2009Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema
Nov 21, 2008FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema
Sep 24, 2008Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema

Further information

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