FDA Approves New Cholesterol Drug, Praluent

Praluent, a new cholesterol-lowering drug, manufactured by Regeneron, was approved this week by the U.S. Food and Drug Administration (FDA), but it won’t be available to everyone, and it will come at a high price.

Praluent is one of a new class of cholesterol-reducing medications called PCSK9, that are being developed by a number of pharmaceutical companies, that could drastically reduce LDL (bad cholesterol) levels in some patients with high cholesterol.

“It represents a new era of hope for us,” said Katherine Wilemon, founder and president of the FH Foundation, in an interview with the New York Times. “We tend to take everything out there that is available, and even with that we can’t get our LDL levels down to a ‘safe’ level.”

Wilemon has a genetic condition knows as familial hypercholesterolemia (FH), that causes dangerously high cholesterol levels; she suffered a heart attack at age 39. Like many with FH, even though she was taking statins to reduce her high cholesterol, her LDL levels remained dangerously high, taking a PCSK9 medication brought her LDL levels down significantly, from 167 down to below 50, finally placing her in the “safe” zone.

Though Wilemon’s experience with the new class of drugs is impressive, medical professionals warn that results like hers may not tell the whole story.

“As a cardiologist, I hope they (the new cholesterol drugs) put me out of business,” said Harlan Krumholz, a professor at Yale Medical School, in an interview with USA Today. “But for some people, their enthusiasm about the potential for the drugs has blinded them to the amount of evidence that’s available.”

Praluent will be available as early as next week, according to CNN, but will only be available to patients to qualify. The FDA put limitations on the distribution of the drug, making it available only to patients with genetically-elevated cholesterol levels like Wilemon, and people who have already experienced a heart attack and/or stroke. But even with the restrictions, doctors are cautious about what they don’t know about the drug.

Known side effects for Praluent are itching, swelling, pain and/or bruising at the injection site, and cold or flu-like symptoms. What is not known, are the long-term side effects of the drug, or if it even works as a preventive for heart attack and stroke.

“I am shocked that the FDA had opened the door this wide for a new medication,” cardiologist Cam Patterson, chief operating officer at New York Presbyterian Hospital/Weill Cornell Medical Center, said in an interview with USA Today. “The FDA has put themselves in a situation where they may have to turn around and reverse their decision.”

In addition to the controversy regarding the effectiveness and/or use of the drug, another controversy surrounding the approval of Praluent is its exorbitant price tag. Praluent will hit the market at a whopping $14,600 annually, a massive increase in the cost of cholesterol-reducing medication, especially when compared to statin drugs like Crestor, that weigh in at about $3,000 annually. Regeneron is not apologizing of their prices.

“We came to a price that is reflective of value, not what the market will bear,” said Elias Zerhouni, head of research and development at Sanofi/Regeneron, in an interview with the New York Times.

The fallout of the sky-high price of the drugs in combination with the millions of Americans who already need and qualify to receive them, could be damaging to the insurance industry and to its customers; and if the FDA approves the medications for more widespread use, thereby broadening the customer base, the financial impact could be significant.

“This will grow the largest drug class in history,” said Steve Miller, senior vice president and chief medical officer at Express Scripts, to USA Today.

He warned that covering the increased cost of drugs could lead to higher insurance costs for everyone, not just patients receiving treatment.

[Image via Regeneron/Praluent.com]