The U.S. FDA has approved evolocumab for patients who are unable to control their bad cholesterol with current treatment options.
U.S. Food and Drug Administration approved Repatha (evolocumab) injection for a select few category of patients who are unable to regulate or reduce their Low-Density Lipoprotein (LDL), or what is commonly referred to as the bad cholesterol, with treatment options that were currently available. Incidentally, evolocumab is the second non-statin drug in its class to be approved to treat high cholesterol, reported MSN.
The FDA had recently approved Sanofi and Regeneron’s Praluent (alirocumab), which falls under a new line of treatment for controlling LDL, shared John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research.
“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. Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem.”
Repatha (evolocumab) and Praluent (alirocumab) are essentially PCSK9 inhibitors and are strictly approved for use in conjunction with diet control and maximally-tolerated statin therapy. Unfortunately, not all who wish to lower their bad cholesterol will have access to evolocumab. Only patients with conditions like heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who are in urgent need of lowering their LDL, will be qualified for use of the drug, reported the Examiner.
Evolocumab is essentially an antibody that seeks and destroys the PCSK9 protein. The protein is notorious at preventing the liver from getting rid of LDL from the bloodstream. Though it may sound good, the drug has its own fair share of side-effects which include back pain, throat and nasal inflammations (nasopharyngitis), respiratory tract infection and even infections at the injection site which includes redness, pain, or bruising. Few patients suffered from allergic reactions, such as rash and hives too. The FDA has strongly recommended that patients should immediately stop the injections if they experience allergic reactions.
However, despite the side-effects, those who were administered the drug during clinical trials, showed an average drop of 60 percent in their unhealthy cholesterol or LDL. This proved that Repatha (evolocumab) can reliably address the LDL levels, which is one of the most common causes during death due to heart diseases in Americans. The drug is marketed by Amgen Inc., of Thousand Oaks, California
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