FDA Approves New Dosing Regimen for Antara
U.S. Food and Drug Administration Approves Supplemental New Drug Application for Antara 130 mg (Fenofibrate Capsules)
Data Supports Label Change for New More Convenient Dosing Regimen
LIBERTY CORNER, N.J., November 14, 2005 -- Reliant Pharmaceuticals, Inc. announced today that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (SNDA) for a new dosing regimen and label change for the Company's fenofibrate therapy, Antara (fenofibrate capsules) 43 mg and 130 mg. The new regimen enables patients to take Antara 130 mg capsules with or without food, increasing convenience for the 15 percent of adults in the United States with elevated triglycerides.
The SNDA approval was based on exclusive clinical data within the Antara label that demonstrated the efficacy of Antara 130 mg capsules on all lipid parameters -- independent of whether the drug was taken with or between meals. The study examined the significant lipid altering effects of Antara 130 mg on 146 hypertriglyceridemic patients (Fredrickson Types IV/V). The trial population (61% male, 39% female) included patients with hypertension (70%), as well as a significant number of patients with diabetes (32%). Patients with diabetes were included in the study as this patient population has higher rates of hypertriglyceridemia compared with the general population.
"The results of this clinical trial are impressive, as many patients with lipid disorders such as high triglycerides and low HDL cholesterol levels also have concomitant medical conditions which require multiple medications, making lipid control difficult," said Michael Davidson, M.D., lead study author and Director, Preventive Cardiology Center and Professor of Medicine for Rush University Medical Center. "Having proven therapies and dosing options will increase patient convenience, allowing patients to take their prescribed medication more easily and manage their condition more effectively."
Over 15 million prescriptions were written in 2004 for fenofibrate therapies, the largest share of which were written for the newer, lower dose, micronized versions of the drug. Antara 130 mg capsules utilize Micro Precision Technology, which delivers the efficacy of older 200 mg fenofibrate formulations in a small, easy to take 130 mg capsule. The National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Guidelines recommend simplifying treatment regimens to improve patient compliance.
"Antara 130 mg, with its unique, low-dose capsule formulation, exclusive clinical data, and newly revised and approved package insert, will play an important role in the future of our Company," said Ernest Mario, Ph.D., Reliant's Chairman and Chief Executive Officer. "With the recent launch of Omacor(R), our potent FDA-approved prescription omega-3 fatty acid, we now have a comprehensive triglyceride portfolio that is unique in the industry."
Antara is indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides, and apo B and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacologic intervention alone has been adequate. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia, thereby obviating the need for pharmacologic intervention.
Antara is contraindicated in patients who exhibit hypersensitivity to fenofibrate. Fenofibrate is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and in patients with unexplained persistent liver function abnormality. Fenofibrate is contraindicated in patients with preexisting gallbladder disease.
Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.
The effect of Antara on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
Source: Reliant Pharmaceuticals, Inc.
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