WASHINGTON, June 11 (UPI) -- Two new drugs that lower cholesterol significantly more than statins were recommended for approval this week by a U.S. Food and Drug Administration advisory panel, bringing them one step closer to full approval for use by doctors.
Although the panel said the drugs should be approved by the FDA, several members stressed caution as clinical trials for both drugs will not be complete until 2017.
The panel also gave guidelines to limit the use of Sanofi's alirocumab and Amgen's evolocumab to patients with an inherited form of high cholesterol called familial hypercholesterolemia, those who cannot tolerate stains, and those who can't get their cholesterol down low enough with other drugs.
Statin drugs are relatively successful in lowering cholesterol, bringing it down by 30 to 40 percent, however the new drugs lower cholesterol by 40 to 60 percent by blocking an enzyme that prevents the liver from filtering bad cholesterol out of the blood.
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The new drugs, which are injectable, as opposed to coming in pill form like statins, are raising hope for patients who cannot get their cholesterol down low enough toward their doctor's goals or who cannot take statins because they either don't work for them or carry a side effect of muscle breakdown and pain.
"While the preliminary data on both drugs are encouraging, there is no substitute for large randomized clinical trials," Dr. Jerome Avorn, a professor of medicine at Harvard, told the New York Times. He adds that the very low LDL levels are so unprecedented, that "it would be cavalier to assume that nothing could possibly go wrong."
