Sanofi/Regeneron PCSK9 lowers cholesterol in diabetes patients

Sanofi and Regeneron have had a tough time of late with their PCSK9-class cholesterol drug, Praluent (alirocumab), as Amgen is attempting to get Praluent removed from the US market in an ongoing patent row.

But at least Sanofi and Regeneron can claim a minor victory with positive data in high cholesterol patients who also have diabetes.

At the American Diabetes Association conference in San Diego, the companies today unveiled two studies that could help them make the case to prescribe Praluent when high cholesterol overlaps with diabetes.

The phase 3 ODYSSEY-DM, showed Praluent significantly reduced “bad” low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes who also had a high cardiovascular risk and hypercholesterolaemia.

Data from a cohort of patients with type 1 diabetes will be published at a later date.

And the ODYSSEY DM-DYSLIPIDEMIA study showed Praluent significantly reduced non-high density lipoprotein cholesterol (non-HDL-C) by 32.5% compared with standard of care in patients with type 2 disease and mixed dyslipidaemia.

Non-HDL-C is considered to be a better predictor of cardiovascular risk than LDL-C levels, particularly in this patient population with type 2 diabetes with mixed dyslipidemia.

Patients who received alirocumab had improvement in other lipid parameters compared to the patients in the usual care group, and the majority of patients in the alirocumab group reached the recommended lipid levels on a lower 75 mg dose.

Earlier this year, Amgen’s rival PCSK-9, Repatha, failed to produce conclusive data showing the drug could reduce cardiac death risk.

Although the data suggested Repatha reduced risk of cardiovascular events, there was no observed effect on cardiovascular mortality.

While Amgen has filed with regulators to include the CV data on its label, Sanofi and Regeneron must wait until the end of the year, or perhaps early 2018, to see whether Praluent can reduce the risk of cardiovascular death in the ODYSSEY OUTCOME trial.

With the outcome of the court case against Amgen also unclear, with key decisions due in autumn or maybe later, this will be the crunch time for Praluent.