Friday, July 24, 2015
The FDA (US Food and Drug Administration) has approved the new cholesterol lowering drug alirocumab, brand name Alirocumab. The injectable drug, from Regeneron and Sanofi, is the first in a new class of drugs called PCSK9 inhibitors.
The drug works by making the liver more efficient at getting rid of LDL, or bad cholesterol.
Alirocumab is approved for patients with heterozygous familial hypercholesterolaemia, an inherited condition that causes high LDL cholesterol levels. It is also approved for patients who have had a heart attack or stroke.
The efficacy and safety of Alirocumab were evaluated in placebo-controlled trials, involving 2,476 patients. All patients had heterozygous familial hypercholesterolaemia (HeFH) or were otherwise at high risk of heart attack or stroke, and were taking maximum tolerated doses of statins, with or without other lipid lowering medication. Participating patients had an average reduction in LDL cholesterol ranging from 35 to 59 percent when compared to the placebo arm.
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