FDA Approval For Amgen, Inc. (AMGN)’s Cholesterol Drug Repatha
The United States FDA has given approval for Amgen, Inc. (NASDAQ:AMGN)’s Repatha injection to control LDL cholesterol. The drug is the second one to be approved in a new drug class known as PCSK9 inhibitors. The approval of use is in addition to diet, as well as, maximally-tolerated statin therapy. The drug is intended for use by adult patients affected by heterozygous familial hypercholesterolemia or HeFH, clinical atheroscierotic cardiovascular disease or homozygous familial hypercholesterolemia or HoFH. It hopes to prevent against patients who have a high risk for strokes or heart attacks and required additional reduction of LDL cholesterol.
High Levels Of LDL Cholesterol
The FDA said that familial hypercholesterolemia included HeFH, as well as, HoFH and an inherited condition causing a higher level of LDL cholesterol. A higher level of this could lead to potential heart ailments. Heart ailments are the number one reason for the death of men and women in the United States. Amgen, Inc. (NASDAQ:AMGN)’s Repatha provides another option of treatment.
The drug maker’s Repatha is an antibody, which targets a specific protein known as PCSK9. That cuts down the receptors in the liver, which take away LDL cholesterol from the blood. The company drug block the ability of PCSK0’s work to free the LDL cholesterol thus resulting in the lowering the levels of LDL cholesterol.
Safety And Efficacy Evaluated
Amgen, Inc. (NASDAQ:AMGN)’s Repatha efficacy, as well as, safety were evaluated during one of the 52-week placebo-controlled studies. Similarly, they were evaluated during the eight 12-week studies in participants with primary hyperlipidemia. That included two specific enrolled participants of HeFH and the other enrolled participants with HoFH.
It was also found during one of the twelve-week trials that participants with HeFH needed additional reduction of LDL cholesterol. They were randomized to get placebo or Repatha for a period of 12-weeks. Those who took Repatha were able to gain an average reduction in LDL cholesterol of about 60% in comparison with placebo. Amgen, Inc. (NASDAQ:AMGN) is marketing Repatha in the United States.
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