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New cholesterol-lowering drug gets federal regulators' approval

Federal drug regulators approved a new cholesterol-lowering medication Friday that doctors are calling a game-changer in the way it reduces the bad form of the compound in the blood.

The medication, called Praluent, is a protein-engineered substance that borrows on technology used to produce targeted cancer drugs in recent years.

U.S. Food and Drug Administration officials approved the medication for specific groups of patients: those who have hereditary conditions that cause their cholesterol levels to skyrocket as well as patients who cannot tolerate statin drugs.

Statins are considered the standard of care for elevated levels of LDL -- low-density lipoprotein -- the bad form of cholesterol.

"There has been a lot of hoopla about this drug at cardiology meetings over the last year or so," said Dr. Richard Shlofmitz, chairman of cardiology at St. Francis Hospital in Flower Hill. "The first important thing is that it doesn't have the same side effects that statins have. And the second, it has to be taken only twice a month, so you don't have to take pills every day."

Praluent, a so-called monoclonal antibody, becomes the first such drug in this country to reduce levels of LDL cholesterol, a key player in the development of arterial plaque. A similar U.S.-manufactured monoclonal antibody was approved earlier this week in Europe.

A monoclonal antibody, generally speaking, is a laboratory cloned protein designed to target a predetermined molecule on a cell and cause that cell to undergo a specific activity. The new drug works in the liver where cholesterol is processed and zeros in on a protein called PCSK9, which normally works by reducing the number of receptors on liver cells.

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Praluent blocks PCSK9, allowing more liver-cell receptors to remain available to remove LDL cholesterol, and that lowers LDL levels.

An estimated 5,000 people were involved in the clinical trials, which led to the drug's approval, said Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston and a member of the steering committee overseeing the 12 studies involving the medication. Half the patients received Praluent; the rest received a statin drug, Cannon said.

Praluent is self-injected by the patient and a key side effect was itching at the injection site, the studies found.

The drug is a product of Regeneron, a biotechnology company in Tarrytown, Westchester County, and Sanofi in Paris. The manufacturers' wholesale acquisition cost -- the price before discounts or rebates -- is $1,120 every 28 days -- according to corporate literature released yesterday.

"This is a new frontier for the management of patients with high cholesterol," said Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in Mineola. "Statins are here to stay. We all look at statins as first-line therapy."

Statins include a large stable of medications -- Lipitor, Crestor, Zocor and Mevacor, for example. Drugs such as these have been prescribed for decades.

But some patients have familial hypercholesterolemia, a condition that can lead to heart attacks early in life and statins cannot sufficiently lower LDL levels, doctors say.

Also, some people, Marzo noted, can't tolerate statin drugs.

"Right now, we try different statins, or have the patient take the medication every other day, until we find that sweet spot," he said of reaching a level of tolerability.In some instances, the sweet spot remains elusive, added Shlofmitz, who noted that some people have complained of muscle weakness and pain; others have complained of memory loss while on a statin.

Statins, nevertheless, have been found to prevent cardiovascular disease and mortality.

Statistics from the Centers for Disease Control and Prevention indicate that more than 600,000 people die of heart disease, about 1 in every 4 deaths annually.

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