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PUBLIC RELEASE DATE:
31-Aug-2014

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ODYSSEY FHI & II -- investigational alirocumab shows lipid-lowering promise

BARCELONA, Spain - Sunday 31 August: An investigational lipid-lowering agent called alirocumab produced superior results compared to placebo in Hot Line studies reported today at ESC Congress 2014.

Alirocumab, is a fully‐human monoclonal antibody and part of a new class of cholesterol-lowering drugs known as PCSK9 (proprotein convertase subtilisin / kexin type 9) inhibitors.

ODYSSEY FH I & II were two studies that evaluated the effect of alirocumab in patients with heterozygous familial hypercholesterolaemia whose low‐density lipoprotein‐cholesterol (LDL‐C) levels were inadequately controlled by their current statin and other lipid-lowering therapy (LLT).

Heterozygous familial hypercholesterolaemia (heFH) is a common inherited disease which causes extremely high levels of LDL-C and increased risk of premature atherosclerosis and cardiovascular disease, explained principal investigator Michel Farnier, MD, PhD, from Point Médical, Dijon, France.

"Patients with heFH are difficult to treat in clinical practice. The actual recommended treatment for this category of patients is a statin at the maximum tolerated dose (mainly atorvastatin or rosuvastatin) and if necessary, combination with other lipid-lowering drugs. However, even at this maximum tolerated treatment, their baseline levels of LDL-C in our studies were relatively high (mean around 3.5 and 3.7mmol/l)," he said.

The double-blind, placebo-controlled trials, conducted in North America, Europe and South Africa, together included a total of 735 heFH patients (aged approximately 52-53 years) who were randomised to receive either a subcutaneous injection of alirocumab 75-150 mg every 2 weeks (n=490 across both studies), or matching placebo (n=245 across both studies) for 78 weeks, in addition to their current therapy.

"It is important to emphasize that in both trials, patients were very well treated before the trial," noted Dr. Farnier. All of them were on statins, with more than 80% on maximum doses, and 55-65% on combination therapy with ezetimibe."

At week 24, alirocumab significantly reduced LDL-C from baseline (mean

48.8% and 48.7% in the ODYSSEY FH I & II studies respectively) compared to increases of 9.1% and 2.8% respectively seen in the placebo-treated arms (P<0.0001). To reach a pre-specified LDL-C level below 1.81 mmol/l (70 mg/dl), an up-titration to 150 mg every 2 weeks was necessary in only about 40 % of patients receiving alirocumab treatment.

Similarly, by week 24, significantly more alirocumab-treated patients compared to those on placebo had reached the LDL-C goal of a level below 2.59 mmol/L (100 mg/dL) in high-risk patients or below 1.81 mmol/L (70 mg/dL) in very high-risk patients (72.2% vs 2.4% in FHI, and 81.4% vs 11.3%; both P<0.0001).

Pooled data from the two studies shows treatment-emergent adverse events occurred in a similar proportion of patients on alirocumab and placebo (74.8% vs 75.4%), leading to study discontinuation in 3.1% and 3.7% patients, respectively.

"Previous studies have shown that only about 20% of heFH patients are able to reach a goal of less than 2.5mmol/l." noted Dr. Farnier. "Due to the dramatic complementary decrease in LDL-C that our studies obtained with alirocumab, this new strategy is particularly important for this category of patients at high risk of cardiovascular disease."

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