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FDA Panel Pushes For Approval Of Amgen's Cholesterol-Lowering Drug Repatha

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US health officials from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the approval of a second new drug that significantly lowers the level of LDL or "bad" cholesterol. The members of the Food and Drug Administration panel, however, say that the drug from Amgen called Repatha, should be used in patients with high risk of heart disease and familial hypercholesterolemia.

The voting records yield 11-4 score in favor of approving the drug. The members who for Repatha say that the benefits of the drug exceed the risks associated with it. However, concerns rise pertaining to the short period of time (12 weeks) it took for the drug study to last.

The panel unanimously voted for the approval of Repatha in treating familial hypercholesterolemia, with a sweep score of 15-0. Familial hypercholesterolemia is the genetically-induced increase in cholesterol levels. Homozygous familial hypercholesterolemia, a rare type of the disease, is noted in approximately 1 in one million individuals.

Repatha, with a generic name of evolocumab, is a monoclonal antibody and a PCSK9 inhibitor. "[The drug] results in statistically significant reductions in LDL cholesterol of approximately 60 percent after 12 and 52 weeks of treatment," states an FDA investigation pertaining to the clinical trial submitted.

The 24 clinical trials were reviewed and published in the Annals of Internal Medicine. The analysis shows that PCSK9 inhibitors reduce the level of LDL cholesterol by an average of 48 percent. The notable finding yielded was that it can help lower the risk of heart attacks and mortalities due to cardiovascular diseases.

"The trials so far have been short-term, and it's not clear whether the new cholesterol drugs really do extend people's lives," says Dr. Seth Martin, a cardiologist at Johns Hopkins University.

Amgen has already nominated 27,000 study subjects to test if Repatha clearly reduces the incidence of heart attacks compared to the widely-used statins alone. The results of the study are expected to be released by 2017.

"For all those patients unable to take statins, finally there might be an option that can change (their) outcomes," says Dr. Suzanne Steinbaum, who was not part of the latest review. "We need to patiently wait for the next phase of trials to see whether the clinical outcomes are as promising as the initial studies suggest."

Photo: Patrick J. Lynch | Flickr

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