Science Magazine says Repatha bare hit primary endpoint

[anonymous]

sciencemag.org/news/2017/03/pricey-new-cholesterol-drug-scrapes-heart-risk-study

In other words, a physician would need to treat about 150 patients with Repatha in a year to prevent one of these bad events, Hiatt explains. “The benefit here is meaningful and substantial,” he says, “although not overwhelming.”

The question insurance companies are grappling with is whether that benefit justifies the list price of nearly $15,000 a year. “It’s an expensive medicine for a common disease, says Kathiresan, “and my sense is that the price will have to come down.”

 

[anonymous]

The Amgen study, while successful, was not all that compelling. Yes, the relative risk for the composite cardiovascular endpoints used in the study went down, but not by as much as observers were hoping for (15% reduction versus 20 or 25%). And when you get down to overall mortality, there was no change at all, which has to be a disappointment. Amgen has been arguing that this was a relatively short study, and that the first measurements were also taken at a relatively early point in the treatment, and that the overall trend is for better numbers as the treatment goes on (which may well continue). But while these points may be valid, it’s a little rich for Amgen to be making them, because they designed this trial themselves, presumably to generate the most compelling results in the shortest amount of time. The fact that they’re having to make such arguments at all is a sign that the trial definitely did not come out the way that they’d hoped – you can be sure that the plan was not to have to say “Well, gosh, it’s really not bad if you look closely”.

 

[anonymous]

Did we learn anything new about who is the right population to get treated? Our view remains heterozygous patients (HeFH) and higher LDLs in the secondary prevention space are the most likely candidates. From our conversations at ACC, we think doctors will still have to make tough decisions about who to attempt to treat due to heavy payer restrictions. Some of our checks called the FOURIER data more of a base hit rather than a home run. Based on the data, doctors seemed skeptical that payer restrictions are lifting anytime soon so doctors will continue to attempt to treat those that would get the highest benefit. Many experts pointed to the Pfizer data where in SPIRE-2 that had higher risk patients (over 100 dl/mL) that the reduction of risk in MACE events was 21% (HR.79, p value .021) with close to 400 events total. Amgen presented an analysis this weekend that about 80% of prescription claims in the US are rejected, and we doubt that changes in the near-term.

What does FOURIER mean for Regeneron’s upcoming ODYSSEY outcomes study? Overall experts felt confident that there was a positive read-through to REGN’s study though there are several important differences. 1) Regeneron’s study population is in acute coronary syndrome patients. There is some belief that these patients will likely benefit greater from LDL lowering unlike some of the populations included in the Amgen study. Patients can enter ODYSSEY 1 month after their acute coronary syndrome. 2) Regeneron is looking for a similar number of events needed at 1,613 (similar to AMGN) but all patients have to be followed for 2 years as well. The last patient in was Nov 2015 which would make results at earliest Nov 2017 from speaking to the presenter. He estimated follow-up time could be 6-7 months longer than FOURIER. 3) Definition of death is coronary heart disease which is a bit more specific; for example, a death related from stroke is not a coronary heart disease death.

 

[anonymous]

At the American College of Cardiology’s annual meeting, Amgen (NASDAQ: AMGN) revealed details of a massive study showing that its cholesterol lowering drug, evolocumab (Repatha), reduced heart attacks and strokes. The company wants insurers to loosen access to the drug, which has struggled in the marketplace. Cardiologists Xconomy spoke with were lukewarm on the drug’s prospects.

 

[anonymous]

Amgen rushed the study because they wanted outcomes first. Study design was terrible, 5,000 patients added half way through study. Most not on what is considered gold standard statins, Zocor.
Most needed to have an event at least three years ago.
Overall Amgen study design group should be fired. Better hope Praluent is better , Novartis HF drug has a 20% decline and that drug is sucking wind. Good luck .
But continue to pay off doctors, vouchers etc and you will be ok.

 

[anonymous]

Amgen rushed the study because they wanted outcomes first. Study design was terrible, 5,000 patients added half way through study. Most not on what is considered gold standard statins, Zocor.
Most needed to have an event at least three years ago.
Overall Amgen study design group should be fired. Better hope Praluent is better , Novartis HF drug has a 20% decline and that drug is sucking wind. Good luck .
But continue to pay off doctors, vouchers etc and you will be ok.

Entresto is also list priced at $4500 a year, 20% in outcomes, a likely a net price of $3000-3500. It's in guidelines as well and still sucking. If you can't win an NBA championship with Michael Jordan, then sure as hell can't find one with a Joe Smoe. Amgen is Joe Smoe and Entresto is Michael Jordan.