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Amgen gets prevention claim for cholesterol drug Repatha

FDA approves new labelling on heart attack and stroke risk reduction

Amgen Repatha

The US FDA has approved new labelling saying that Amgen’s cholesterol drug Repatha can reduce the risk of heart attacks and strokes, which the company hopes will accelerate sales.

The new label gives Amgen a promotional edge for Repatha (evolcoumab) over rival PCSK9 inhibitor Praluent (alirocumab) from Sanofi and Regeneron as it tries to rev up sales of its product, which have so far failed to live up to early expectations.

Repatha brought in $89m in sales in the third quarter of this year, more than twice the same period in 2016 but still well short of what Amgen hoped for when it launched the drug in 2015. It has always maintained that the slow take-up has been caused by a reluctance by healthcare payers to fund treatment with the drug based on cholesterol-lowering data alone.

An estimated 75% of patients prescribed the medicine have been denied coverage despite numerous appeals, severely holding back sales, reports Reuters. The approval will allow Amgen to start promoting Repatha's ability to reduce heart attacks and strokes with both physicians and patients in the US.

Amgen CEO Robert Bradway said a few weeks ago that “improving patient access to Repatha remains a top priority for our team”, adding that the cardiovascular outcomes data will be a key factor in that effort. “I remain optimistic that Repatha will become a significant product for Amgen as it also brings a compelling value proposition to patients,” he added.

The new label is based on the results of the FOURIER trial, which showed that the drug reduced the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularisation procedures by 22% over a two year-period when added to statin therapy.

“In the US, every 40 seconds someone has a heart attack or stroke, and nearly one in three of these patients will have another event, leading to a societal cost that exceeds $600bn annually,” said Amgen’s head of commercial Anthony Hooper.

“With this approval, it's now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes.”

Outcomes data for Praluent is not due until next year, and in the meantime Sanofi and Regeneron are locked in patent litigation with Amgen that could have a dramatic impact on their ability to sell the PCSK9 inhibitor in the US market.

Article by
Phil Taylor

4th December 2017

From: Regulatory

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