Amgen's Repatha Results Not Good Enough For The Street

It is why millions of people take drugs called statins to reduce the amount of bad cholesterol. In the FOURIER study, Repatha dropped LDL cholesterol in patients by 59% compared to placebo.

Results from the long-awaited Fourier trial, created to test Amgen's Repatha as a tool to cut cardiovascular risks, showed that the drug scythed heart attack risks by 27% over the course of the study, which followed patients for an average of two years.

"However, the trial was stopped early after only 2.2 years of average follow-up and therefore it is hard to be certain about the actual extent of the longer term benefit, including the impact on dying from heart disease, as well as longer term safety". At one year, there was a 16% relative risk reduction for the combination of cardiovascular death, heart attack and stroke. There were no new safety concerns identified in the trial, either.

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The simplest explanation is that the markets wanted to see an even greater cardiovascular risk reduction. This raises the concern that insurers might not be willing to remove numerous restrictions that they have placed on accessing Repatha unless Amgen is willing to give in on pricing.

The cost varies, but it is thought to cost the UK's NHS about £2,000 per year per patient where it is already being given to people who do not respond to statins. Investors were particularly disappointed that the study did not show the drug reduced deaths, analysts said.

"With this trial, we now have definitive data that by adding evolocumab to a background of statin therapy, we can significantly improve cardiovascular outcomes and do so safely", said Marc S. Sabatine, MD, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine at Brigham and Women's Hospital in Boston, chair of the Thrombolysis in Myocardial Infarction (TIMI) study group and the study's lead author. That's believed by many to make it a more attractive option than now available PCSK9 inhibitors, which require monthly or bi-weekly injections. However, the cholesterol lowering effect tended to diminish over time in some patients and bococizumab did not reduce cardiovascular event rates among those with LDL levels lower than 100 mg/dL. Traders believed that Amgen's positive announcement would increase the chances of bempedoic acid winning FDA approval by 2020, once its Phase 3 safety and efficacy studies are completed. Regeneron's stock fell by more than 4% while Sanofi is down by just over 1%, most likely because Sanofi has a more diversified product portfolio.

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This last result is something insurers care about - preventing costly health care. These two companies are also funding an expensive long-term cardiovascular study called ODYSSEY OUTCOMES that is expected to wrap up later this year. Amgen announced in February that the drug was a success, but details of the research were not released until Friday.

Amgen Inc ( AMGN ) said that the 27,564-patient Repatha or evolocumab cardiovascular outcomes study, FOURIER, established for the first time that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible with the current best therapy alone, leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations.

If Amgen's data don't move the needle and Repatha remains a blockbuster interrupted, there could be a chilling effect on cardiovascular R&D in the drug industry. Unfortunately, it is still too early to know the answer to that question.

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The global team, which includes researchers from Imperial College London, says the drug could provide added benefit to patients already taking statins by further reducing the levels of low-density lipoprotein (LDL) cholesterol in their blood.


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