Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD(TM), An Investigational Treatment For Mixed Dyslipidemia

Main Category: Endocrinology
Also Included In: Cholesterol;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 05 Jun 2009 - 2:00 PDT

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Abbott (NYSE: ABT) and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol (the "bad" cholesterol), high triglycerides and low HDL-cholesterol (the "good" cholesterol). The NDA submission for this investigational compound, containing the active ingredients of CRESTOR(R) (rosuvastatin calcium) and TRILIPIX(R) (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD(TM).

"The NDA submission is an important milestone in the development of CERTRIAD and demonstrates our commitment to developing treatments for dyslipidemia," said Howard Hutchinson, chief medical officer, AstraZeneca. "We look forward to continued discussions with the FDA about this potential new medicine."

"Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "If approved, CERTRIAD could become an important treatment option for physicians looking to provide comprehensive management of mixed dyslipidemia to their patients."

According to the American Heart Association, more than 100 million adults in the United States have dyslipidemia. Of those, approximately 34 million people are affected by mixed dyslipidemia. Treatment guidelines endorsed by the National Cholesterol Education Program (NCEP), the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as well as more aggressive management of HDL and triglycerides.

About CERTRIAD(TM)

CERTRIAD is an investigational compound containing the active ingredients of CRESTOR and TRILIPIX under development by Abbott and AstraZeneca for the treatment of mixed dyslipidemia. Phase III studies, which have been presented at multiple scientific forums, were designed to evaluate the effect of CERTRIAD on HDL and triglycerides compared to rosuvastatin monotherapy and the effect on LDL compared to fenofibric acid monotherapy in patients with mixed dyslipidemia.

About CRESTOR

CRESTOR is indicated as adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to reduce cardiovascular morbidity and mortality. For patients with hyperlipidemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. The 40-mg dose of CRESTOR is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20-mg dose of CRESTOR once daily. When initiating statin therapy or switching from another statin therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy.

Important Safety Information

CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product and in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are or may become pregnant, and in nursing mothers. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with drugs in this class, including CRESTOR. These risks can occur at any dose level but are increased at the highest dose (40 mg). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir.

Combination therapy with rosuvastatin and gemfibrozil should be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. The most frequent adverse reactions thought to be related to CRESTOR were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).(1,2)

About TRILIPIX

TRILIPIX (fenofibric acid) delayed-release capsules is a prescription medicine used along with a low-fat and low-cholesterol diet in adults to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can be used alone. It can also be used to lower triglycerides and increase HDL cholesterol in patients with heart disease or who are at risk of heart disease and who are taking a statin medicine to control their LDL cholesterol. TRILIPIX has not been shown to prevent heart disease or heart attacks or stroke more than a statin alone.

Important Safety Information About TRILIPIX

TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient. Unexplained muscle pain, tenderness, or weakness, particularly when occurring with tiredness and fever, may be a sign of a serious side effect and should be reported to a healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and can be fatal. The risk of these side effects may be increased when TRILIPIX is used with a statin. Patients should tell their healthcare provider about all the medicines they take to help avoid serious side effects. Blood tests may be performed before and during treatment with TRILIPIX to check for liver or kidney problems. Patients should contact their healthcare provider if they experience abdominal pain, nausea, or vomiting while taking TRILIPIX.

These may be signs of inflammation of the gallbladder or pancreas. Women who are pregnant should not take statins and should talk with their healthcare provider about TRILIPIX if they are pregnant or may become pregnant. The most common side effects with TRILIPIX include headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that are measured by blood tests.

About AstraZeneca

AstraZeneca is engaged in the research, development, manufacturing, and marketing of meaningful prescription medicines and in the supply of health care services. AstraZeneca is one of the world's leading pharmaceutical companies with global health care sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar health care business.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

Source: AstraZeneca