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December 24, 2012
07:45 EDTAEGRAegerion announces Boxed Warning for newly-FDA approved Juxtapid
Juxtapid contains a Boxed Warning citing the risk of hepatic toxicity. The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia, or HoFH, who do not have HoFH. The effect of Juxtapid on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of Juxtapid have not been established in pediatric patients. The FDA based its approval of Juxtapid on Aegerion's pivotal Phase III study, which evaluated the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH. In this study, Juxtapid was initiated at 5 mg daily and gradually escalated to doses of 10 mg, 20 mg, 40 mg, up to 60 mg, based on tolerability and acceptable liver enzymes levels. The most common adverse reactions in the Phase III trial were gastrointestinal. Adverse reactions included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain, influenza, nasopharyngitis, and fatigue. Elevations in liver enzymes and hepatic fat were also observed.
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April 9, 2014
08:08 EDTAEGRAegerion initiates Phase 3 clinical trial for lomitapide in Japan
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April 8, 2014
11:03 EDTAEGRPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.

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