Amgen, Sanofi and Regeneron trot out new PCSK9 data at European heart meeting

Praluent and Repatha

Amgen, Sanofi and Regeneron are awaiting much-anticipated outcomes data on their PCSK9 cholesterol-fighters--data payers and doctors see as key for adoption of the $14,000-plus meds.

But that doesn’t mean the companies aren’t rolling out other studies in the meantime to help bolster their case for the drugs.

At the European Society of Cardiology meeting over the weekend, Amgen unveiled two analyses on its Repatha drug, while Sanofi and Regeneron touted numbers on Praluent.

The two Repatha analyses looked at the drug in a variety of patient groups. One dug into numbers on patients segmented into four groups by their cardiac risks. That study, which drew on data from three late-stage trials, showed that Repatha beat placebo and Merck’s Zetia at lowering LDL cholesterol in all of the risk groups. In patients at very high risk, as defined by ESC criteria, Repatha cut LDL 65% better than placebo did, and 40% better than Zetia (ezetimibe).

The other looked at long-term data on patients with a hereditary form of high cholesterol, heterozygous familial hypercholesterolemia. Repatha treatment for 48 weeks cut LDL cholesterol in a “persistent and marked” way, the company said. Patients receiving standard treatment saw a 2.1% increase, whereas those using Repatha cut their LDL levels by 53%. The data came from patients in two Repatha trials who went on to participate in longer-term extension trials.

"These analyses continue to shape the clinical evidence for Repatha and help to advance our understanding of its potential to benefit patients," Amgen R&D chief Sean E. Harper said in a statement.

Meanwhile, Sanofi and Regeneron unveiled detailed data from the Odyssey Escape study, which focused on patients whose bad cholesterol (LDL) levels are so high, they require a special treatment to pull it from their blood. Patients who needed weekly or biweekly apheresis saw the frequency of those treatments reduced by 75% when they added Praluent to their regimens, compared with patients in the placebo arm.

The study, one in a suite of Praluent trials, was designed to show that Praluent is cost-effective for these patients--even at a $14,000-plus list price. Apheresis is expensive--up to $100,000 per patient per year in the U.S.

Almost two-thirds of patients (65%) in the Praluent group no longer needed aphaeresis at all, while none of the placebo patients could stop the treatments, the companies said. Overall, 93% of Praluent patients saw their apheresis treatments drop by at least half, the companies said. The Praluent study was published concurrently in the European Heart Journal.

The companies are racking up data in an attempt to persuade payers--and doctors--that the pricey drugs deliver benefits worth their cost. Two different cost-effectiveness analyses have found that the companies would need to cut the prices of the drugs by two-thirds or more to make them truly cost-effective; Amgen, Sanofi and Regeneron have taken issue with the conclusions, citing discounts off list prices, among other things.

Payers have slapped prior authorization hurdles on the drugs to limit uptake and spending, and many doctors say they're waiting for the outcomes data to see whether to use the drugs broadly. If the outcomes trials show that Praluent and Repatha significantly cut the risk of cardiovascular events--such as heart attacks--then the calculus should change dramatically.

When that data hit, though, another competitor may be nearing launch: Pfizer's bococizumab, which could enter the market just as the long-term case for PCSK9 meds is finally made--provided the outcomes trials succeed, of course.

Related Articles:
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Regeneron CEO pushes back on pricing criticism of new gen cholesterol meds
Pfizer's bococizumab may hit the PCSK9 market just in time
Amgen nabs another PCSK9 exclusive, this time with giant CVS
NICE, in reversal, OKs Amgen's Repatha while snubbing Sanofi and Regeneron's Praluent
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