ADA: Praluent data positive in diabetes patients
- Sanofi and Regeneron Pharmaceuticals unveiled positive results from their ODYSSEY DM Phase 3b/4 trials of Praluent (alirocumab) in patients with diabetes, at the 77th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, CA, this weekend.
- When dosed along with maximally-tolerated doses (MTD) of statins, Praluent significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with type 1 or type 2 diabetes (48.2% reduction from baseline compared with 0.8% increase for placebo; p<0.0001). In the ODYSSEY DM-DYSLIPIDEMIA study, Praluent was superior to standard-of-care in reducing non-high-density lipoprotein cholesterol (non-HDL-C) (37.3% reduction compared with 4.7% reduction for SoC; p<0.0001).
- Most patients reached their goals with Praluent dosed every two weeks. Safety profiles were similar to those seen in previous Phase 3 studies.
Many people with diabetes also have increased risk of atherosclerotic cardiovascular disease, and almost 70% of diabetes patients aged 65 or older will die of some form of heart disease, and around 16% will die of a stroke. Treating mixed dyslipidemia in people with type 2 diabetes is challenging.
"The results of ODYSSEY DM-DYSLIPIDEMIA showed that in a real-world setting, Praluent, on top of maximally tolerated doses of statins, significantly reduced non-HDL-C, another measure of bad cholesterol, and was superior to usual care. Praluent may be another option for physicians who need to further help their diabetes patients with clinical ASCVD manage their lipid profiles," said Robert Henry, member of the ODYSSEY DM Steering Committee and Director of the Center for Metabolic Research at the VA San Diego Healthcare System.
The long awaited ODYSSEY OUTCOMES study is expected to read out in 2017, following a decision from an independent data monitoring committee that stated that the study had not reached the level of efficacy that would allow it to stop early, as the companies had hoped.
Praluent sales in the U.S. have faced a challenge in the U.S., since Amgen won a federal court victory as part of its patent value that pitches Praluent against Amgen's Repatha (evolocumab). This grants a permanent injunction against Sanofi and Regeneron, and in effect bans sales of Praluent in the U.S. In February, Regeneron and Sanofi gained a temporary reprieve and launched an appeal against the ruling, and is hoping for a ruling as early as this month.
Despite the ongoing legal battle between the two competitors, sales of the PCSK9 inhibitors have not gotten off the ground. Both Praluent and Repatha have failed to gain market share against the low-cost generic statins that are widely available on the market.
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