SAN DIEGO—Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent. But the pair now has results in hand suggesting the med can safely cut "bad" cholesterol in Type 2 diabetes patients at high risk of CV problems.
On Sunday at the American Diabetes Association’s annual meeting, the companies unveiled two studies that fall under the Odyssey outcomes trial umbrella. In the first, dubbed Odyssey DM-Insulin, Praluent slashed low-density lipoprotein (LDL) cholesterol by 49% compared with placebo in insulin-treated Type 2 diabetes patients with both high cardiovascular risk and high levels of the so-called bad cholesterol not controlled by maximum tolerated doses of statins.
And that wasn’t all. Eighty percent of Praluent patients reached their recommended target LDL-C goal, and researchers declared it safe for Praluent and insulin to be taken together. Praluent was also generally well-tolerated, the companies said, and it didn’t affect glucose control.
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The second study, meanwhile, examined patients with Type 2 diabetes, high CV risk and mixed dyslipidemia, or elevations in non-high-density lipoprotein (HDL) cholesterol and triglyceride levels that are often accompanied by low levels of HDL. In that study, Praluent beat standard of care at cutting non-HDL—considered a better predictor of cardiovascular risk than LDL levels, particularly in that patient population—by 32.5%.
Patients in that study's Praluent group saw improvement in other lipid measures, too, such as LDL. And once again, the med was generally well-tolerated and didn’t interfere with glucose control.
The two sets of results are good news for diabetes patients, many of whom—despite the current standard of care for lowering lipids—have “persistent lipid abnormalities resulting in increased residual cardiovascular risk,” study co-chair Lawrence Leiter, M.D., said in a statement.
"Results of these studies provide healthcare professionals with valuable new information about managing cholesterol in people with diabetes at high CV risk who are unable to attain their cholesterol goals with statins or other lipid-lowering therapies," a Sanofi spokesperson added via email.
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And the results are also good news for Sanofi and Regeneron, which are eagerly awaiting the broader Odyssey Outcomes results. Data from the trial, which involves more than 18,000 patients from 57 countries, will be key for convincing payers to shell out on the pricey med, something they’ve so far been reluctant to do.
And if they’re positive, they could also prove critical in establishing a lead over Amgen nemesis Repatha, which is already out with lukewarm outcomes data of its own. Earlier this year, the company revealed that Repatha hadn’t delivered a decrease in cardiac death risk, leaving analysts and investors skeptical that payers would broaden their coverage. Since then, however, Amgen struck a pay-for-performance deal with Harvard Pilgrim, which ties rebates to Repatha's results and includes a refund for patients who suffer heart attacks while taking the med.
Outcomes results, though, are not the only thing Sanofi and Regeneron are eagerly awaiting. They’re also biding their time until a court hands down its decision in a high-stakes patent fight between the partners and Amgen, which could force Praluent off the market.