TARRYTOWN, N.Y., and
PARIS, Sept. 1, 2015 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that, in a new pooled analysis of heterozygous familial
hypercholesterolemia (HeFH) patients included in the ODYSSEY
clinical trial program, Praluent® (alirocumab)
significantly reduced bad cholesterol, known as low-density
lipoprotein cholesterol (LDL-C).1 This analysis included
1,257 HeFH patients, the largest group of HeFH patients ever
studied in a Phase 3 program. At week 24, when the primary efficacy
endpoint was assessed, patients treated with Praluent had an
average 56 percent greater reduction in LDL-C compared to placebo
(p less than 0.0001) in both arms.1 Reductions were
observed as early as week 4 and were maintained for the duration of
therapy, until week 78.1
Results of this analysis were presented today at the ESC
Congress 2015 in London, and the
78 week results from two of the four trials included in the
analysis, ODYSSEY FH I and II, were concurrently published online
in the European Heart Journal.
"Approximately 20 percent of HeFH patients achieve LDL-C less
than 100 mg/dL with statins. In this analysis, up to 75 percent of
patients who added Praluent to standard-of-care achieved their
LDL-C goals by week 24," said John J. P.
Kastelein, M.D., Ph.D., FESC, Professor of Medicine,
Department of Vascular Medicine, Academic Medical Center/University
of Amsterdam, the Netherlands.
"Both Praluent 75 mg and 150 mg significantly reduced LDL-C levels
below 100 mg/dL and sustained these lower levels through 78 weeks,
offering patients and their doctors a flexible approach to
treatment, with adverse events comparable to placebo."
Across the pooled analysis, the most common adverse events
(occurring in at least five percent of patients in any Praluent
group) were nasopharyngitis, injection site reaction, influenza,
headache, upper respiratory tract infection, arthralgia, back pain,
urinary tract infection and myalgia.1
People with HeFH have an inherited form of high cholesterol and
are unable to process the body's natural supply of cholesterol in
the liver, leading to very high levels of LDL-C that can block
arteries (atherosclerosis) and can lead to a heart attack or
stroke.3,4 If left untreated, people with HeFH typically
have LDL-C levels of 200-400 milligrams/deciliter
(mg/dL),5 are at high risk for premature atherosclerosis
and cardiovascular (CV) events, and are at 20 times greater risk of
developing heart disease.3,4
The analysis presented at ESC Congress 2015 evaluated the
efficacy and safety of Praluent compared to placebo in 1,257
patients with HeFH. Data from four Phase 3 ODYSSEY trials, LONG
TERM (HeFH patients only), HIGH FH, FH I, and FH II, were included
in the analysis. In these trials, patients either received Praluent
or placebo, in addition to standard-of-care, which included
maximally-tolerated statins with or without other lipid-lowering
therapies such as ezetimibe. In ODYSSEY LONG TERM and HIGH FH,
patients were treated with Praluent 150 mg (n=348) every two weeks
administered as a single 1-milliliter (mL) injection or placebo
(n=174).1 In these patients, the average LDL-C at
baseline was 168 mg/dL and 162 mg/dL in the Praluent and placebo
groups respectively.1 In ODYSSEY FH I and FH II,
patients were treated with Praluent 75 mg (n=490) every two weeks
administered as a single 1-mL injection or placebo
(n=245).1 In ODYSSEY FH I and FH II, patients had their
dose adjusted to 150 mg at week 12 if they did not achieve their
pre-specified LDL-C goal at week 8. In these patients, the average
LDL-C level at baseline was 141 mg/dL in both the Praluent and
placebo groups.1
Across all primary and secondary endpoints assessed, there were
statistical differences in favor of Praluent compared to
placebo.1 Patients treated with Praluent achieved
average LDL-C levels of less than 85 mg/dL at week 12,6
and maintained reductions through 78 weeks of
therapy.1
Summary of Primary and Select Secondary Endpoints
|
Baseline
LDL-C
|
% LDL-C
reduction
from
baseline (week 24)a
|
% achieved
LDL-C
goalb (week 24)
|
Greater %
reduction for
Praluent vs. placebo groups (on-treatment analysis)c
|
Week
24
|
Week
52
|
Week
78
|
Initially treated
with 75 mg (FH I and FH II)
|
Praluent
|
141
|
49d
|
75d
|
56d
|
58d
|
56d
|
Placebo
|
141
|
-7
|
5
|
Initially treated
with 150 mg (LONG TERM and HIGH FH)
|
Praluent
|
168
|
55
|
64.5
|
57
|
60
|
63
|
Placebo
|
162
|
-1
|
4
|
Note: p less than 0.0001 vs. placebo for all data points
a Primary efficacy endpoint
b LDL-C goal either 70 mg/dL or 100 mg/dL depending on
baseline CV risk
c On-treatment analysis (all other data is
intention-to-treat)
d Includes 42 percent of patients treated with Praluent
who had their dose adjusted to 150 mg at week 12
Praluent, a human monoclonal antibody targeting PCSK9
(proprotein convertase subtilisin/kexin type 9), is approved for
use in the U.S. as an adjunct to diet and maximally tolerated
statin therapy for the treatment of adults with HeFH or clinical
atherosclerotic CV disease (ASCVD), who require additional lowering
of LDL-C. The effect of Praluent on CV morbidity and mortality has
not been determined. In July, the European Medicines Agency's
(EMA's) Committee for Medicinal Products for Human Use (CHMP)
recommended the approval of Praluent in certain adult patients with
hypercholesterolemia, and a final decision from the European
Commission is anticipated in September.
Important Safety Information for U.S.
Do not
use PRALUENT if you are allergic to alirocumab or to any of the
ingredients in PRALUENT.
Before you start using PRALUENT, tell your healthcare provider
about all your medical conditions, including allergies, and if you
are pregnant or plan to become pregnant or if you are breastfeeding
or plan to breastfeed.
Tell your healthcare provider or pharmacist about any
prescription and over-the-counter medicines you are taking or plan
to take, including natural or herbal remedies.
PRALUENT can cause serious side effects, including allergic
reactions that can be severe and require treatment in a hospital.
Call your healthcare provider or go to the nearest hospital
emergency room right away if you have any symptoms of an allergic
reaction including a severe rash, redness, severe itching, a
swollen face, or trouble breathing.
The most common side effects of PRALUENT include: redness,
itching, swelling, or pain/tenderness at the injection site,
symptoms of the common cold, and flu or flu-like symptoms. Tell
your healthcare provider if you have any side effect that bothers
you or that does not go away.
Talk to your doctor about the right way to prepare and give
yourself a PRALUENT injection and follow the "Instructions for Use"
that comes with Praluent.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing
Information
References
- Kastelein JJP, Farnier M, Hovingh GK, et al. Efficacy and
safety of the PCSK9 monoclonal antibody alirocumab vs placebo in
1257 patients with heterozygous familial hypercholesterolaemia:
analyses up to 78 weeks from four ODYSSEY trials. Oral presentation
at ESC Congress 2015 (#5772): 29 August-2
September 2015.
- Kastelein JJP, Ginsberg HN, Langslet G, et al. ODYSSEY FH I and
FH II: 78 week results with alirocumab treatment in 735 patients
with heterozygous familial hypercholesterolaemia. European Heart
Journal 2015: doi:10.1093/eurheartj/ehv370.
- FH Foundation. What is FH? Available from:
http://thefhfoundation.org/about-fh/what-is-fh/ Last accessed
6 August 2015.
- Goldberg AC, Hopkins PN, Toth PP et al. Familial
Hypercholesterolemia: Screening, diagnosis and management of
pediatric and adult patients. J Clin Lipidol.
2011;5:S1–S8.
- Reiner Z, Catapano AL, De Backer G, et al. The Task Force for
the management of dyslipidaemias of the European Society of
Cardiology (ESC) and the European Atherosclerosis Society (EAS):
ESC/EAS Guidelines for the management of dyslipidaemias.
European Heart Journal 2011: 32;1769–1818.
- Kastelein JJP, Farnier M, Hovingh GK, et al. Efficacy and
safety of the PCSK9 monoclonal antibody alirocumab vs placebo in
1257 patients with heterozygous familial hypercholesterolaemia:
analyses up to 78 weeks from four ODYSSEY trials. Abstract from the
ESC Congress 2015: 29 August-2 September
2015.
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 have 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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now underway or planned, including without limitation
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Contacts Sanofi:
Media
Relations
Jack
Cox
Tel: +33 (0) 1 53 77
94 74
Mobile: +33 (0) 6 78
52 05 36
Jack.Cox@sanofi.com
Global
Communications, PCSK9 Development & Launch Unit
Elizabeth
Baxter
Mobile (onsite at
ESC): +1 (908)
340-7811
Elizabeth.Baxter@sanofi.com
|
Investor
Relations
Sebastien
Martel
Tel: +33 (0)1 53 77
45 45
IR@sanofi.com
|
Contacts Regeneron:
Media Relations
Hala
Mirza
Mobile (onsite at
ESC): + 1 (917) 929-1734
hala.mirza@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.