KalbitorTreatment for Angioedema
Update: Kalbitor (ecallantide) Now FDA Approved - November 27, 2009
FDA Advisory Committee to Review DX-88
Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 13, 2009--Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee is scheduled to discuss the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) on February 4, 2009. An advisory committee is a group of experts that provides the FDA with advice and is convened by the FDA as part of its review of a novel therapy.
If DX-88 receives FDA approval, it would become the first product to be indicated for the treatment of acute attacks of HAE in the U.S. Dyax submitted its BLA for DX-88 on September 23, 2008, and was designated for Priority Review upon FDA acceptance of the application. With Priority Review designation, which is intended for those products that address unmet medical needs, DX-88's Prescription Drug User Fee Act (PDUFA) target action date is March 23, 2009.
"With no treatment approved for acute attacks of HAE in the U.S., a new therapy for this debilitating and life-threatening disease remains a priority," commented Gustav A. Christensen, President and Chief Executive Officer of Dyax. "DX-88 meets a number of criteria cited as important by both patients and physicians and was tested in a Phase 3 clinical program representing the largest placebo-controlled evaluation of any drug developed to treat this disease. We look forward to presenting the results of these trials and other data from our comprehensive HAE program to the committee and continuing to advance the BLA for DX-88."
The BLA submission was based primarily on data from two placebo-controlled Phase 3 clinical trials, known as the EDEMA3 and EDEMA4. In those trials, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints and was found to be well tolerated.
About DX-88 for HAE
The recombinant, small protein, DX-88 (ecallantide), was discovered utilizing Dyax's proprietary phage display technology. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and is being evaluated as a subcutaneous therapy for treating acute HAE attacks.
Hereditary Angioedema (HAE) is an acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, the larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood.
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently being evaluated for its therapeutic potential in two separate indications. On November 21, 2008, the U.S. Food and Drug Administration (FDA) accepted for filing the Company's Biologics License Application for approval of DX-88 for the treatment of hereditary angioedema (HAE) and designated the application for Priority Review. Based on this designation, the FDA Prescription Drug User Fee Act (PDUFA) target action date is March 23, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for the treatment of acute attacks of HAE. Additionally, DX-88 is being evaluated for the prevention of blood loss during on-pump cardiothoracic surgery (CTS) through its partner, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 and other compounds in Dyax's pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
This press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of DX-88 for HAE and the timing and prospects for review and FDA approval of the BLA for DX-88. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the prospects for therapeutic benefits and treatment advantages of DX-88 for HAE, and the timing and prospects for review and FDA approval of the BLA for DX-88, include the risks that: DX-88 may not show sufficient therapeutic effect in clinical trials or could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that gain greater market acceptance because they are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials and manufacture of DX-88; and other risk factors described or referred to Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax and the Dyax logo are registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are registered service marks of Dyax.
CONTACT: Dyax Corp.
Ivana Magovcevic-Liebisch, 617-250-5759
Executive Vice President of Administration
and General Counsel
Nicole Jones, 617-250-5744
Director, Investor Relations
Source: Dyax Corp.
Posted: January 2009
- FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older - April 7, 2014
- Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older - December 2, 2009
- Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema - June 8, 2009
- Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema - March 27, 2009
- FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema - February 5, 2009
- FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema - November 21, 2008
- Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema - September 24, 2008