Patients and doctors across the country are getting excited about a class of drugs that promise to drop patients’ cholesterol levels to unprecedented lows. What’s more, the pharmaceutical company that developed the first of these drugs, alirocumab, just received support for its approval from the U.S. Food and Drug Administration (FDA) advisory committee, Time.com reports.
Findings from studies of drugs in this class showed that some patients’ LDL cholesterol levels dropped as low as those found in infants. The drugs are called PCSK9 inhibitors. They work by helping the body produce more LDL cholesterol receptors on liver cells that pull cholesterol out of the blood like a sponge and keep blood vessels clear of potential clogs.
Researchers said they were inspired to develop the drugs by the fact that some people are born with a genetic mutation that makes them naturally deficient in the PCSK9 enzyme. People deficient in this enzyme have naturally low LDL cholesterol levels and heart disease risk throughout their lives (with no adverse health effects reported).
Scientists noted that nearly all patients taking the drugs, (via an injection dispensed either every two weeks or once a month) experienced drops in their LDL cholesterol levels of up to 65 percent. In addition, researchers saw some patients’ LDL levels drop to levels of 25mg/dL—much lower than current heart disease recommendations of 70mg/dL or less.
The FDA’s advisory committee voted 13 to 3 to recommend approval of alirocumab because they felt it was safe enough and provided significant benefits over existing heart disease therapies, such as statins
But critics voiced concern about the advisory committee’s recommendation because there aren’t any long-term studies about how patients on the treatment fare over time.
For more information about how cholesterol influences heart disease risk, click here.
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