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PHARMA - CORONARY ARTERY DISEASE
TREATMENT |
Aceon approved for heart disease treatment in US
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BY OUR PHARMA CORRESPONDENT
25 August, 2005: The US Food and Drug Administration (FDA) has approved Aceon tablets for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction (MI), announced Solvay Pharmaceuticals, Inc. and CV Therapeutics, Inc, co-promoters of the drug.
Aceon contains perindopril erbumine active ingredient. Prior to this labeling expansion, the drug was indicated for the treatment of essential hypertension.
The new indication is based on the EUROPA (EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study. EUROPA was a multicenter, randomized, double-blind, placebo-controlled trial in 12,218 patients with stable coronary disease and without heart failure, which assessed the ability of perindopril to reduce cardiovascular death, non-fatal MI or cardiac arrest. Patients had a mean follow-up of 4.2 years.
In this study, in a broad population of patients with stable coronary artery disease, there was a 20 percent reduction in the combined endpoint of cardiovascular mortality, non-fatal MI and cardiac arrest compared to placebo. This significant (p=0.0003) reduction in relative risk was seen in patients on a treatment regimen of 8 mg of perindopril, including patients treated with conventional cardiovascular preventive therapy, such as aspirin, other anti-coagulants, beta-blockers and other anti-hypertensive therapy and lipid lowering therapy, such as statins. Patients not randomized to receive perindopril received placebo in addition to their conventional therapy.
EUROPA study demonstrated that perindopril can provide benefit in stable coronary artery disease patients with or without hypertension and in a broad range of younger and older patients, when used in combination with current conventional therapy, said the press statement.
CV Therapeutics and Solvay Pharmaceuticals entered into a co-promotion agreement for Aceon in December 2004. CV Therapeutics is responsible for brand marketing activities and has established a cardiovascular specialty sales force to promote the product. Solvay Pharmaceuticals continues to handle the manufacturing and distribution of the product, and its primary care sales force also continues to promote the product. Solvay Pharmaceuticals books all sales of Aceon and CV Therapeutics will receive a share of sales above a pre-specified baseline. There were no upfront payments by either party associated with the co-promotion agreement.
ACE inhibitors act to reduce hypertension by interfering with the conversion of angiotensin I to artery-constricting angiotensin II. Blocking the production of angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure.
Aceon is indicated to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction in patients with stable coronary artery disease and also is indicated for the treatment of patients with essential hypertension.
In the EUROPA study, the 20 percent reduction in the risk of cardiovascular events with Aceon 8 mg was observed in a broad range of older and younger stable coronary artery disease patients with or without hypertension or previous MI, and including patients treated with a background of conventional therapies for the management of coronary artery disease.
Aceon offers continuous 24-hour blood pressure control with once-daily dosing. Aceon may be used alone or with other classes of antihypertensives.
Solvay is an international chemicals and pharmaceuticals group with headquarters in Brussels. It employs more than 30,000 people in 50 countries. In 2004 consolidated sales amounted to EUR 7.9 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. Solvay is listed on the Euronext 100 index of top European companies.
BY OUR PHARMA CORRESPONDENT
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