Sanofi and Regeneron Announce New Praluent® (alirocumab) Injection Analyses Presented at AHA Scientific Sessions 2015

BRIDGEWATER, N.J. and TARRYTOWN, N.Y., Nov. 10, 2015 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced a new post-hoc analysis of six Phase 3 clinical trials showing that approximately three quarters (74 percent) of patients reached their pre-specified LDL cholesterol targets within 8 weeks of adding Praluent^® (alirocumab) Injection 75 mg to their standard-of-care, which included statins. In the 26 percent of patients whose dose was increased to 150 mg, most were able to achieve their pre-specified LDL cholesterol target, with an average additional 14 percent reduction in LDL cholesterol. The results from this and other analyses, which evaluated Praluent every two weeks, were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, FL.

"In this analysis of patients who required further improvement of their LDL cholesterol levels, adding Praluent 75 mg to their standard-of-care allowed the majority of patients to achieve their LDL cholesterol goals. For those who required further LDL cholesterol lowering, increasing Praluent to 150 mg provided additional efficacy," said Harold Bays, M.D., from the Louisville Metabolic & Atherosclerosis Research Center, Kentucky, U.S. "Data such as these provide clinicians practical insight as to how the two Praluent doses may better allow patients to achieve their LDL cholesterol goals."

These results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol (heterozygous familial hypercholesterolemia, or HeFH) which found 74 percent of patients who added Praluent 75 mg achieved their LDL cholesterol-lowering goals at week 8, and the remaining 26 percent had their dose adjusted to 150 mg at week 12. In other results:

• By week 24, 61 percent of patients who switched to 150 mg achieved their goal, with a mean additional LDL cholesterol reduction of 14 percent.
• Comparable adverse event (AE) rates were observed in patients whose Praluent dose was increased, versus those whose dose was not (66 percent in both arms in placebo-controlled trials; and 55 percent versus 56 percent respectively in ezetimibe-controlled trials).
• About the data: The pooled analysis included results from six Phase 3 ODYSSEY trials where patients added Praluent 75 mg to standard-of-care, and had their dose adjusted at week 12 to 150 mg if they did not reach their LDL cholesterol goals by week 8. Cholesterol goals were either less than 70 mg/dL or less than 100 mg/dL, dependent on CV risk. All patients across the six trials received background statin therapy. In three trials Praluent was compared to placebo (ODYSSEY FH I, FH II, COMBO I), and in three it was compared to ezetimibe (ODYSSEY COMBO II, OPTIONS I, OPTIONS II).

In a separate pooled post-hoc analysis of 3,499 patients, individuals with diabetes (n=1,051) who initially received Praluent 75 mg or 150 mg every two weeks had a mean percent difference in LDL cholesterol of 44 percent and 58 percent, respectively, versus placebo at week 24 (p<0.0001). In other results:

• Praluent was generally well tolerated, with the most common adverse events among people with diabetes being nasopharyngitis (11 percent Praluent, 10 percent placebo) and upper respiratory tract infection (8 percent Praluent, 9 percent placebo).
• About the data: The pooled analysis included results from five placebo-controlled trials of individuals with diabetes (1,051), and without diabetes (2,448) with inadequately controlled hypercholesterolemia receiving standard-of-care, which included maximally-tolerated statins. In two of the trials, patients initially received Praluent 150 mg (ODYSSEY LONG TERM, HIGH FH). In three of the trials, patients initially received Praluent 75 mg and had their dose adjusted to 150 mg at week 12 if they required additional lipid-lowering to meet their LDL cholesterol goals (ODYSSEY COMBO I, FH I, FH II).

A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related AEs among those who didn't have diabetes when they entered the trials, regardless of whether they were taking Praluent or were in a control group (placebo or ezetimibe). There was also no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes. The ongoing ODYSSEY OUTCOMES trial will provide further data on the impact of Praluent on glycemic measures.

• About the data: The pooled analysis included results from 10 Phase 3 ODYSSEY trials of patients with inadequately controlled hypercholesterolemia, ranging from 24 to 78 weeks (ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II, MONO, ALTERNATIVE). In total, 1,526 (31 percent) had a medical history of diabetes upon entering the trials, 1,969 (40 percent) were identified as having pre-diabetes, and 1,479 (30 percent) did not have diabetes (e.g., had a normal concentration of glucose in the blood).

About Praluent
In July, the companies announced that Praluent was approved for use in the U.S. Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol. The effect of Praluent on CV morbidity and mortality has not been determined.

In September, the European Commission approved the marketing authorization for Praluent. In the E.U., Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not yet been determined.  

IMPORTANT SAFETY INFORMATION FOR U.S.
PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT. Reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.

Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.

The most commonly occurring adverse reactions (>5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.

Local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo.

Neurocognitive events were reported in 0.8% of patients treated with PRALUENT and 0.7% of patients treated with placebo. Confusion or memory impairment were reported more frequently by those treated with PRALUENT (0.2% for each) than in those treated with placebo (<0.1% for each).

Liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo.

The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).

PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT.

Please click here for the full Prescribing Information

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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Regeneron Forward-Looking Statements and Use of Digital Media
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