High levels of low-density lipoprotein (LDL) cholesterol in the blood causes plaque buildup in the arteries and eventually leads to heart disease. This is the leading cause of death for Americans and kills about 610,000 people every year. US regulators have now approved Repatha, the second injectable drug of its kind designed for certain patients with stubbornly high cholesterol which puts them at risk of heart disease. These new drugs offer an alternative to popular anti-cholesterol drugs known as statins (Lipitor, Crestor and others) which are not tolerated by all patients.
Repatha is also known as evolocumab. It is made by Amgen and is part of a new class of drugs known as PCSK9 inhibitors, or antibodies which work on the liver to lower cholesterol. It was approved by the US Food and Drug Administration (FDA) for people with inherited conditions that cause high levels of LDL, or bad cholesterol, as well as people whose clogged arteries have led to heart disease.
John Jenkins, director of the Office of New Drugs at the Center for Drug Evaluation and Research, said, "Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins."
One study on Repatha revealed that patients taking it for 12 weeks saw a 60% reduction in LDL levels, compared to patients taking a placebo. Side effects of Repatha may include upper respiratory tract infection, flu, back pain and reactions such as redness, pain or bruising where the injection is given. The FDA also warned that some patients may have allergic reactions.
An advisory panel to the FDA recommended the drug's approval in June, 2015. Data on whether the new drug actually leads to longer lives or less heart disease will not be available until 2017. Pharmaceutical companies suggest that the drugs could help between eight and 11 million Americans.