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
This news release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Praluent® (alirocumab) Injection; unforeseen safety
issues and possible liability resulting from the administration of
products (including without limitation Praluent) and product
candidates in patients; serious complications or side effects in
connection with the use of Regeneron's products and product
candidates in clinical trials, such as the ODYSSEY OUTCOMES trial
evaluating Praluent; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products (such as Praluent),
research and clinical programs, and business, including those
relating to the enrollment, completion, and meeting of the relevant
endpoints of post-approval studies (such as the ODYSSEY OUTCOMES
trial prospectively assessing the potential of Praluent to
demonstrate cardiovascular benefit); determinations by regulatory
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associated with intellectual property of other parties and pending
or future litigation relating thereto. A more complete description
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including its Form 10-K for the year ended December 31, 2014 and its Form 10-Q for the
quarterly period ended September 30,
2015. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
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limitation any financial projection or guidance, whether as a
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Regeneron uses its media and investor relations website and
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Contacts Sanofi:
Media
Relations
Carrie Brown Tel: +1 (908) 981-6486
Carrie.Brown@sanofi.com
|
Global
Communications, PCSK9 Development & Launch Unit
Elizabeth
Baxter
Mobile (onsite at
AHA): +1 (908)
340-7811
Elizabeth.Baxter@sanofi.com
|
Contact Regeneron:
Media Relations
Arleen
Goldenberg
Tel: +1 (914)
847-3456
Mobile: +1 (914)
260-8788
Arleen.Goldenberg@regeneron.com
|
|
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SOURCE Sanofi