FDA Approves Praluent a Pricey New Cholesterol-lowering Drug

On July 24, 2015, the U.S. Food & Drug Administration approved Praluent (alirocumab) the first in a new class of cholesterol-lowering drugs known as PCSK9 inhibitors (protein convertase subtilisin kexin type 9). This new class of medications hold the promise of reducing heart attacks and strokes, which kill approximately 610,000 Americans every year. The PCSK9 acts by blocking a substance that hinders the liver’s ability to remove LDL (bad cholesterol) from the blood. Praluent is self-injected by the patient every two weeks.

The FDA has approved Praluent in adults who have (HeFH), or patients with cardiovascular diseases who have not been able to lower their LDL cholesterol enough with traditional statins.

According to the FDA, the efficacy and safety of Praluent were evaluated in five different clinical trials, which involved 2,476 patients who were exposed to the drug. All participants in the trial were at increased risk of heart attack and stroke. Those participants who received Praluent had an average reduction in LDL cholesterol between 36 to 59 percent while statins alone can lower cholesterol by 25 to 35 percent. A trial is ongoing that will evaluate whether adding Praluent to statins reduces cardiovascular risk.

Potential problems

One troubling development, however, is the price tag of the new drug. Traditional statins cost around $4 per day, while this new drug will cost $40 per day and more than $14,000 per year, which is raising significant concerns about the affordability of the drug for those who need it and for those whose lives could potentially be saved by taking it.

Some of the side effects from Praluent include:

• Itching
• Swelling
• Bruising at the injection site
• Nasopharyngitis
• Flu

Some allergic reactions such as hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization have been reported with the use of Praluent. The FDA recommends that patients who experience an allergic reaction should get immediate medical attention.

In a Washington Post article, Jay Edelberg, head of the PCSK9 development team at Sanofi said, “The clinical studies we’ve done to date really have shown exactly what we’ve hoped for, which is a truly unprecedented ability to lower LDL cholesterol,” he said. “The ability to lower LDL for these high-risk patients is incredibly important.”