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Amgen's Repatha Reduces Bad Cholestrol in Type II Diabetes

Wednesday, June 27, 2018   (0 Comments)
Posted by: Kate Oesterle
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Amgen  AMGN announced new data from the phase III study - BANTING - which showed that its PCSK9 inhibitor, Repatha, significantly reduced bad cholesterol in patients with type II diabetes and hypercholesterolemia already receiving moderate/high-intensity statin therapy. The data was presented at Annual Scientific Sessions of the American Diabetes Association over the weekend.

According to the data from the BANTING study, the addition of Repatha to background statin therapy significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C). Notably, LDL-C was reduced by 53.1% at week 12 from baseline in the patient population.

So far this year, Amgen's shares have gained 6.5%, comparing favorably with the industry 's 5.7% decrease.

The BANTING study evaluated monthly subcutaneous administration of a 420 mg dose of Repatha over a period of 12-weeks in patients with type II diabetes and hypercholesterolemia or mixed dyslipidemia who are on optimized background statin therapy.

The encouraging data from the study shows that patients with type II diabetes and hypercholesterolemia, who are already treated with a maximum tolerable dose of statin therapy, can further reduce LDL-C and non-HDL-C by adding Repatha.

Data from the BANTING study also revealed that 84.5% of patients in the Repatha arm achieved LDL-C levels of less than 70 mg/dL, which is the recommended level by American College of Clinical Endocrinologists for patients with type II diabetes, compared with 15.4% of patients in placebo arm at week 12. The addition of Repatha too reduced various lipid parameters, including non-HDL-C by 47% compared with 1% for placebo.

High non-HDL-C levels can cause cardiovascular events in type II diabetes patients, which in combination with LDL-C increases the risk further.

We remind investors that Repatha's label was expanded in Europe last month to include prevention of heart attack and stroke in adults with established cardiovascular disease. The encouraging data from BANTING study further brightens the prospect of the drug in reducing cardiovascular events in presumably larger patient population.

Another PCSK9 inhibitor available in the market is Sanofi SNY , and partner Regeneron Pharmaceuticals, Inc.'s REGN Praluent. Currently, both the drugs have recorded lower-than-expected sales due to higher pricing and re-imbursement issues/payer restrictions.

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