PHARMACY

Study: Genzyme, Isis cholesterol drug lowers LDL levels

BY Alaric DeArment

CAMBRIDGE, Mass. A drug for treating a genetic cholesterol disorder decreased levels of “bad” LDL cholesterol in patients, according to results of a late-stage clinical trial announced Wednesday.

Genzyme Corp. and Isis Pharmaceuticals announced results of a 124-patient phase 3 study of mipomersen for treating heterozygous familial hypercholesterolemia, a disease in which the body is unable to process LDL cholesterol. Patients with the disease carry a high risk of premature cardiovascular disease and death.

According to the study results, mipomersen reduced LDL cholesterol levels by 28%, thus meeting the trial’s primary goal. All of the patients in the study had pre-existing coronary artery disease and were taking statins and other lipid-lowering drugs. The companies said the trial also met its three secondary goals, with reductions of apolipoprotein B – a major component of LDL cholesterol – total cholesterol and non-HDL cholesterol.

“We are excited by these strong data in the second phase 3 trial of mipomersen,” Genzyme chief medical officer Richard Moscicki said. “This therapy has the potential to make a major difference in the lives of patients who are in great need of new treatment options.”

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FDA approves expanded use of Crestor

BY Alaric DeArment

WILMINGTON, Del. The Food and Drug Administration has approved a new use for a cardiovascular drug made by AstraZeneca, the drug maker announced Monday.

The FDA approved Crestor (rosuvastatin calcium) for reducing the risk of stroke, heart attack and surgical restoration of blood flow – known as arterial revascularization – in patients without obvious coronary heart disease but an increased risk of cardiovascular disease based on age, presence of risk factors for cardiovascular disease and quantities of high-sensitivity C-reactive protein in the blood of 2-mg per liter or more. Crestor already had approval for treating other cardiovascular health risks when used along with changes in diet.

“Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication,” AstraZeneca chief medical officer Howard Hutchinson stated.

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CMS: U.S. health spending hits $2.5 trillion as Rx costs reach $246 billion

BY Jim Frederick

WASHINGTON Healthcare spending in the United States climbed 5.7% to $2.5 trillion in 2009, despite the impact of a struggling economy, according to projections issued by the Centers for Medicare and Medicaid Services and published in the journal Health Affairs.

Healthcare expenditures now comprise 17.3% of the nation’s total gross domestic product, CMS estimated. Over the next decade, the agency predicted, health spending will jump at an average rate of 6.1% a year, versus a projected average annual gain of 4.4% for the overall GDP.

With more Americans losing their insurance and Medicaid enrollments rising, public spending for health care will continue to grow faster than health spending in the private sector, the government predicted.

The rise in total health costs was not quite matched by the growth of prescription drug spending, CMS economists estimated. Total prescription drug spending rose a projected 5.2% last year, the agency reported in Health Affairs, to a U.S. total of $246.3 billion.

That marks an accelerating trend for drug spending, according to the journal, which cited “an increase in per person use of drugs, driven by the need for antiviral drugs to treat H1N1, and by higher price growth in brand-name drugs.”

Long-term growth of both overall healthcare expenditures and the prescription drug market will continue at a steady clip, government analysts predict. CMS pegs total drug expenditures at $457.8 billion by 2019, Health Affairs reported, “with spending growth expected to accelerate over the projection period due primarily to increases in drug prices.”

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