Amgen's Repatha lowers plaque in arteries



New research shows that Amgen's Repatha, part of a new class of treatments that dramatically lower cholesterol known as PCSK9 inhibitors, decreased the amount of plaque in patients with heart catheters.

The FDA approved Repatha as a treatment for heterozygous familial hypercholesterolemia and homozygous familial hypercholesterolemia, two diseases characterized by high levels of LDL cholesterol.  Repatha was also approved for patients with heart disease who require additional cholesterol-lowering beyond what statins can provide. 

The company presented the data Tuesday at the American Heart Association's annual meeting in New Orleans.

See also: Drugmakers condemn ICER-funded study on PCSK9s

In the Phase-III trial, 64% of patients had a decline in the plaque in their arteries when taking both Repatha and a statin, compared with 47% of patients who saw a decrease in plaque when they just took a statin. The buildup of plaque can lead to heart disease, heart attack, or stroke.

Mizuho Securities analyst Salim Syed wrote in an investor note that since the drug showed a decrease in plaque buildup that the data suggests a possible cardiovascular outcomes benefit for Repatha but cautioned that the trial does not measure endpoints for outcomes such as reducing the risk of heart attack or stroke. Amgen is currently conducting an outcomes trial for Repatha that is expected to be completed in November. The company said in an investor call Tuesday night that it is now "more confident" in the success of that outcomes trial following this data. 

See also: Amgen wins PCSK9 patent case against Sanofi and Regeneron

Analysts had expected the drugs to garner blockbuster status but uptake has been slower than expected. Amgen reported $31 million U.S. sales for Repatha in the third quarter of 2016. The only other approved PCSK9 inhibitor, Sanofi and Regeneron's Praluent, reported U.S. sales of $58 million during the same three-month period. 

Leerink analyst Geoffrey Porges analyst recently told STAT that the launches of Amgen's Repatha and Sanofi and Regeneron's Praluent are “close to, if not the biggest, wastes of development and commercial investment in recent industry history.”

Correction: An earlier version of this article misstated the percentage of patients who saw a decrease in plaque in their arteries when just taking a statin.