Aegerion
Pharmaceuticals, Inc. AEGR, a biopharmaceutical company dedicated
to the development and commercialization of innovative therapies for
patients with debilitating rare diseases, today presented detailed one-year
data from the Company's Lomitapide Observational Worldwide Evaluation
Registry (LOWER) study, which showed safety and efficacy results consistent
with those observed in the pivotal study of lomitapide in adult patients
with homozygous familial hypercholesterolemia (HoFH). There were no new
safety signals. Lomitapide, marketed as JUXTAPID(R) capsules in the U.S., is
a microsomal triglyceride transfer protein inhibitor indicated in the U.S.
as an adjunct to a low-fat diet and other lipid lowering treatments,
including apheresis where available, to reduce low-density lipoprotein
cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and
non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with
HoFH. Lomitapide is also approved, with a comparable indication, under the
brand name LOJUXTA(R) in the European Union.
LOWER is a global, long-term, prospective, observational registry of the
long-term safety and effectiveness of lomitapide in clinical practice. These
and future data from LOWER will provide further information about the
long-term safety and effectiveness of lomitapide in a real world setting. At
least 300 patients treated with lomitapide in a commercial setting will be
followed for a minimum of 10 years. These data were presented in a poster
entitled "Lomitapide Observational Worldwide Evaluation Registry (LOWER):
One-Year Data" at the 2015 American Heart Association's (AHA) Scientific
Sessions in Orlando, Florida.
Mark Sumeray, MD, Chief Medical Officer of Aegerion commented, "These new
lomitapide data continue to show consistent and clinically meaningful
efficacy in patients diagnosed with HoFH. In addition, the safety and
tolerability of lomitapide appears consistent with the Phase 3 study that
was the basis for JUXTAPID approval from the US Food and Drug Administration
and other approvals of lomitapide globally."
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