Sanofi and Amgen, eyeing boost for PCSK9 use, tout benefits for diabetes patients

At last week's EASD meeting, Amgen and Sanofi unveiled new numbers showing the benefits of their PCSK9 drugs for patients with diabetes. (Susanne Wysocki Fotographie courtesy EASD)

The stepped-up focus on cardiovascular risks for diabetes patients isn’t an accident. Drugmakers have conducted enormous trials to gauge those risks—and, in some cases, prove their meds can actually fend them off.

But it’s not just diabetes drugs in that spotlight. Just look at two sets of cholesterol drug numbers unveiled a few days ago by Sanofi and Regeneron, on one hand, and Amgen on the other. They're making a case that their PCSK9 cholesterol drugs, whose launches haven't been as quick as expected, deliver reductions in CV risks and risk factors, even in patients who've suffered from diabetes for decades.

“The majority of patients who live with diabetes are at high risk and may suffer from myocardial infarction or strokes,” Jay Edelberg, VP and head of cardiovascular development at Sanofi, said Friday. “We know that very very close management of glucose is important for microvascular complications” such as peripheral neuropathy and wound healing problems.

But lipid levels need to be reduced to cut “macrovascular” problems, i.e., heart attacks and strokes, Edelberg said—along with blood pressure control, smoking cessation and other typical interventions, of course.

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Amgen’s new study backed up that contention, while offering some Repatha-specific outcomes numbers. In an analysis of Fourier, its cardiovascular outcomes trial, diabetes patients were shown to have a greater risk of cardiovascular complications and death.

Cutting cholesterol with Repatha helped turn those risks around—and by a bigger margin in diabetes patients than in those without the disease, though the difference was small. Absolute risks were cut by 2.7% for the diabetes group versus 1.8% for patients without diabetes. Much of the additional benefit for diabetes patients came from a reduction in bypass surgeries. Importantly, however, the risk reductions grew as Repatha therapy continued.

Sanofi and Regeneron don’t yet have an outcomes study to draw from—those data are due in the next few months—but in newly presented data, their PCSK9 inhibitor Praluent showed it could slash bad cholesterol levels in Type 1 and Type 2 diabetes patients taking insulin, without affecting their blood sugar control, and do it better than another class of cholesterol-fighters, fenofibrates.

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Patients in the Odyssey-DM study were at high risk of CV problems and had already tried the standard therapy, statin meds. They had either found statins intolerable or failed to see sufficient improvement in their lipid levels at the highest doses they could tolerate. Some of those patients also were taking add-ons such as Zetia (ezetemibe).

The Type 1 benefits were most notable, Edelberg said, because Type 2 patients are studied more closely. “Our Type 1 patients are individuals with the longest-standing diabetes, and they’re completely insulin-dependent,” he pointed out. “They have extraordinarily high cardiovascular risks. This study showed Praluent could lower LDL quickly and meaningfully in Type 1, with no impact on overall glycemic control for patients.”

Amgen, and Sanofi and Regeneron, continue to roll out new studies on their PCSK9 meds, hoping to build up scripts for the drugs, which have shown they can slash LDL cholesterol but carry price tags of $7,000 or so even after discounts and rebates.

Repatha and Praluent hit the market as all-but-certain blockbuster-earners for their companies, but, so far, those rollouts aren’t hot tickets, partly because of payer foot-dragging, partly because of price tags, which run north of $14,000 on a list basis, but far lower in the real world. Some outcomes data recently posted by Amgen’s Repatha—and forthcoming for the Regeneron and Sanofi drug—could help turn the tide, but that’s not guaranteed