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Amgen Goes 6 for 6 Fighting Cholesterol

Brian Orelli
February 1, 2014

Bust out the brooms; Amgen's (NASDAQ: AMGN) evolocumab has swept its phase 3 program so far.

In the last month and a half, the biotech has announced positive results for four phase 3 trials for the cholesterol-lowering drug. One trial combined evolocumab with statins in patients with high cholesterol. Another tested evolocumab in patients who couldn't take statins. The third trial placed patients on the drug for a year as a test of safety. And the fourth tested patients who were not receiving any lipid-lowering therapy prior to entering the trial.

On Thursday, Amgen announced positive results for two more trials.

One trial tested patients with heterozygous familial hypercholesterolemia. These patients have a mutation in one of the two copies of genes in the cholesterol pathway. While not as bad as the homozygous form in which patients have two mutated copies, patients with heterozygous familial hypercholesterolemia have high cardiovascular risk due to high cholesterol levels.

Adding evolocumab to statins and other lipid-lowering drugs helped patients lower their bad LDL cholesterol compared to placebo plus other therapies.

Almost as an aside -- because it's not nearly as important -- Amgen also said that a usability study testing patient's ability to self-administer an injection of evolocumab was also successful. One of the treatment regimens calls for dosing every two weeks, so not having to go into the doctor's office twice a month would be a huge advantage.

There are 13 phase 3 trials in Amgen's evolocumab program, so we're almost halfway to the finish line. Amgen intends to apply for FDA approval later this year.

Positive, but by how much?
Besides telling investors that the drug passed its primary endpoints of reducing bad cholesterol, the press release didn't have any actual efficacy data: "The mean percent reductions in LDL