Aegerion Pharmaceuticals, Inc. (AEGR)' JUXTAPID() (Lomitapide) Capsules Approved In Canada For The Treatment Of Homozygous Familial Hypercholesterolemia (Hofh)
2/11/2014 7:11:55 AM
Aegerion Pharmaceuticals' JUXTAPID(TM) (lomitapide) Capsules Approved in Canada for the Treatment of Homozygous Familial Hypercholesterolemia (HoFH)
TORONTO, Feb. 11, 2014 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced that Health Canada has granted a Notice of Compliance (NOC) approving JUXTAPID as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH).
HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C ("bad" cholesterol) from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
"HoFH is a challenging disease in which patients experience severe elevations in LDL-C," said Dr. Robert Hegele, MD, (Western University and London Health Sciences Centre). "The approval of JUXTAPID is an especially encouraging event for the Quebec region, where there is a higher prevalence of HoFH based upon a founder effect," said Dr. Jacques Genest, MD (McGill University).
Based on the risk of liver toxicity, JUXTAPID is subject to a risk management plan. Due to its benefit-risk profile, the prescribing of JUXTAPID should be limited to physicians experienced in the diagnosis and treatment of familial hypercholesterolemia. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.
Aegerion also announced the opening of its Canadian headquarters in Toronto, Ontario.
"We expect Canada to be an important market for Aegerion, and with infrastructure in place, we look forward to providing JUXTAPID to HoFH patients in need of therapy," said Marc Beer, Chief Executive Officer of Aegerion. "We have established relationships with thought leaders in this region, and look forward to continued collaboration with physicians to benefit HoFH patients."
"On behalf of patients with rare diseases, we are delighted that Aegerion is not only bringing important innovative products but also setting up a presence in Canada to better address the unmet needs of Canadians," said Durhane Wong-Rieger, President of Canadian Organization for Rare Disorders (CORD).
About Aegerion Pharmaceuticals
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases. Our first approved product, JUXTAPID(TM), is an oral once-daily capsule that offers a treatment option to patients with homozygous familial hypercholesterolemia (HoFH) -- a severe lipid disorder. For more information about the company, please visit www.aegerion.com or www.aegerion.ca.
This press release contains forward-looking statements, including statements regarding the availability of JUXTAPID and launch of JUXTAPID in Canada and the potential for JUXTAPID as a treatment for HoFH. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other factors: the risk that reimbursement of JUXTAPID may not be approved by government or key private payers in Canada at levels that we plan to seek or at all; the risk that JUXTAPID may not gain market acceptance; and the risk that restrictions imposed by regulatory authorities or the side effect profile may limit the commercial potential of JUXTAPID. For additional disclosure regarding these and other risks we face, see the disclosure contained in our public filings with the U.S. Securities and Exchange Commission (available on the SEC's website at http://www.sec.gov), including the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Aegerion Pharmaceuticals, Inc.
Amanda Murphy, Manager of IR/PR
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