How Amgen Can Disrupt the Market for Cholesterol Drugs

The U.S. Food and Drug Administration (FDA) recently approved a brand new cholesterol-lowering drug Repatha (evolovumab). Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.

In simpler terms, Repatha makes the liver more efficient by getting rid of bad cholesterol, or LDL.

There are roughly 11 million people with ASCVD and/or familial hypercholesterolemia (FH).

In patients with clinical ASCVD or HeFH, Repatha reduced LDL-C by approximately 54% to 77% compared with placebo. In a pivotal Phase 3 trial, 90% of clinical ASCVD patients who received Repatha in addition to maximum doses of statins achieved a LDL-C level less than 70 mg/dL. In patients with HoFH, Repatha reduced LDL-C by approximately 30% compared with placebo.

Marc Sabatine, M.D., MPH, chairman of the TIMI Study Group, the Lewis Dexter, stated:

Through PCSK9 inhibition, evolocumab substantially reduces LDL or ‘bad’ cholesterol, a well-validated, modifiable risk factor for cardiovascular disease. Many patients still require further LDL cholesterol lowering and evolocumab now offers an important new treatment option for them.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, added:

We are excited about today’s approval of Repatha in the U.S. as patients and physicians will now have a new treatment option to lower LDL cholesterol,” “Data from key clinical studies have shown that Repatha significantly reduces LDL cholesterol in patients who have not been able to lower their LDL cholesterol through diet and statins alone. At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease.

Realistically speaking, this could be a huge market disrupter within the cholesterol field. Other major cholesterol drugs such as Crestor or Lipitor from AstraZeneca and Pfizer, respectively, could suffer from this introduction of Repatha. However, both Crestor and Lipitor are already suffering from slumping sales in 2014.

Shares of Amgen were up fractionally to $156.30 Friday morning, in a 52-week trading range of $127.07 to $181.81. The stock has a consensus analyst price target of $186.27.

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