Patients with uncontrollably high cholesterol may now undergo medication, thanks to a cholesterol-lowering drug that could have great benefits to cardiovascular care.
The US Food and Drug Administration (FDA) recommended the approval of the drug in June, and finally gave the good-to-go signal Friday.
Sanofi and Regeneron announced the FDA's approval of Praluent injection, the high LDL cholesterol treatment and the first PCSK9 Inhibitor in the US.
According to Regeneron, Praluent will be available to adult patients next week. The drug will come in two doses in a prefilled pen, and patients can administer it on their own, once every two weeks. A month's supply will cost roughly $1,200. Of course, the cost will also depend on a patient's insurance plan.
The drugs were described by the American Heart Association president Dr. Elliott Antman described the drugs as a "powerful new way of lowering the bad form of cholesterol." Antman added the importance of Praluent in having profound implications on vascular diseases.
The drug helps the liver more efficiently get rid of LDL cholesterol.
"It focuses on those who've truly had clinical disease or those who start out with such high levels of LDL," said New York's Mt. Sinai Hospital associate professor of medicine and cardiology Dr. Donald A. Smith. The medicine and cardiology expert believes that these people are at the most risk and they cannot get to where they should be with such conditions.
The drug was approved by the FDA for patients who have heterozygous familial hypercholesterolemia, also known as HeFh. HeFh is an inherited condition that results in high levels of LDL cholesterol. It was also signaled good-to-go for patients who had a stroke or heart attack.
Researchers tested Praluent in the Phase 3 ODYSSEY program, and found consistent results compared with placebo and statins. The program evaluated 150 mg of the drug every two weeks and found a 58 percent reduction in LDL cholesterol levels in patients by the 24th week. At 75 mg, Praluent resulted in a 44 percent LDL cholesterol level reduction by the 24th week.
Another new drug that serves the same purpose as Praluent, Repatha, was also recommended to the FDA by the same committee. Europe has already approved the drug last week, but is still being considered for approval in the US by the FDA.
