Dyax Receives FDA Approval to Expand Use of KALBITOR® (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioed...
April 03 2014 - 4:05PM
Business Wire
Dyax Corp. (NASDAQ:DYAX) today announced that the U.S. Food and
Drug Administration (FDA) has approved an expansion of the
indication for KALBITOR (ecallantide), a peptide inhibitor of
plasma kallikrein used in the treatment of acute hereditary
angioedema (HAE) attacks, to include patients 12 years of age and
older. With this approval, KALBITOR is the first and only
subcutaneous therapy available to treat acute attacks of HAE in
patients 12 years of age and older. KALBITOR is also the only
therapy that is not purified from human plasma that has been
approved to treat this patient group.
The FDA approval of this label expansion for KALBITOR is
supported by the results from two previously completed Phase 3
placebo-controlled clinical studies, known as EDEMA3® and EDEMA4®
as well as the results of study DX-88/19, which was ongoing at the
time of the original approval of KALBITOR. The efficacy and safety
profile observed in pediatric patients 12 years of age and older is
similar to the adult population.
“KALBITOR has an established track record in the HAE marketplace
and this FDA approval for the expanded use in pediatric patients is
an important achievement for both Dyax and the children and
families who are affected by this disease,” said Gustav
Christensen, President and Chief Executive Officer of Dyax. “We
remain committed to providing access to novel therapeutics and
first-class patient services to the HAE community.”
About KALBITOR (ecallantide)KALBITOR is a plasma
kallikrein inhibitor indicated for the treatment of acute attacks
of HAE in patients 12 years of age and older. KALBITOR, which was
discovered and developed by Dyax, was the first subcutaneous
treatment available in the U.S. for treating acute HAE attacks.
Anaphylaxis has been reported after administration of KALBITOR.
Because of the risk of anaphylaxis, KALBITOR should only be
administered by a healthcare professional with appropriate medical
support to manage anaphylaxis and HAE.
For additional information about KALBITOR, including full
prescribing information, please visit www.KALBITOR.com.
About Hereditary Angioedema (HAE)HAE is a rare acute
inflammatory condition characterized by episodes of severe, often
painful swelling affecting the extremities, gastrointestinal tract,
genitalia, and 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. HAE is estimated to affect
up to 1 in 50,000 individuals. Learn more at www.HAEHope.com.
About DyaxDyax is a fully integrated biopharmaceutical
company focused on the discovery, development and commercialization
of novel biotherapeutics for unmet medical needs. The Company
currently markets KALBITOR for the treatment of acute attacks of
HAE in patients 12 years of age and older. Dyax is also developing
DX-2930 for the prophylactic treatment of HAE. Additionally, the
Company owns an internally-developed biomarker assay that detects
activated plasma kallikrein in blood and is being used for internal
research and development efforts, including the exploration and
identification of other plasma-kallikrein-mediated indications
beyond HAE.
Both KALBITOR and DX-2930 were identified using Dyax's patented
phage display technology. Dyax has broadly licensed this technology
and has a portfolio of product candidates being developed by our
licensees, which it refers to as the Licensing and Funded Research
Portfolio (LFRP). The Company is eligible to receive future
milestones and/or royalties dependent upon the development and
commercialization of these candidates.
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full
prescribing information, please visit www.KALBITOR.com.
DisclaimerThis press release contains forward-looking
statements. 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 future performance
include the risks that: KALBITOR and/or DX-2930 may face
competition from other products that are developed and/or marketed
to treat HAE; KALBITOR and/or DX-2930 may not gain market
acceptance; Dyax is dependent on the expertise, effort,
priorities and contractual obligations of third parties in the
manufacture, marketing, sales and distribution of KALBITOR and
DX-2930; and other risk factors described or referred to in 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, the Dyax logo and KALBITOR are registered
trademarks of Dyax Corp.
Dyax Corp.Jennifer Robinson, 617-250-5741Associate
Director,Investor Relations and Corporate
Communicationsjrobinson@dyax.com
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