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2015-09-01

Sanofi : Sanofi and Regeneron Announce New Positive Praluent® (alirocumab) Phase 3 Data Presented at ESC Congress 2015

Sanofi and Regeneron Announce New Positive Praluent®(alirocumab) Phase 3 Data
Presented at ESC Congress 2015

- Largest Phase 3 analysis of patients with familial hypercholesterolemia
showed adding Praluent to standard-of-care therapy reduced LDL-cholesterol by
an average 56 percent compared to standard-of-care alone1-

- Data from select familial hypercholesterolemia trials

concurrently published in the European Heart Journal2-

Paris and Tarrytown, New York - September 1, 2015
-
SanofiandRegeneron Pharmaceuticals, Inc.announced today 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).1This 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<0.0001) in both arms.1Reductions 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,
Amsterdam."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 5 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.3,4If left untreated, people with HeFH
typically have LDL-C levels of 200-400 milligrams/deciliter (mg/dL),5are at
high risk for premature atherosclerosis and cardiovascular (CV) events, and
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).1In these patients, the
average LDL-C at baseline was 168 mg/dL and 162 mg/dL in the Praluent and
placebo groups respectively.1In 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).1In 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.1Patients treated with
Praluent achieved average LDL-C levels of less than 85 mg/dL at week 12,6and
maintained reductions through 78 weeks of therapy.1

Summary of Primary and Select Secondary Endpoints

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Baseline LDL-C % LDL-C reduction from baseline % achieved LDL-C goalb Greater % reduction for Praluent vs. placebo groups |
| (week 24)a (week 24) |
| (on-treatment analysis)c |
| Week 24 Week 52 Week 78 |
| Initially treated with 75 mg Praluent 141 49d 75d 56d 58d 56d |
| |
| |
|(FH I and FH II) |
| Placebo 141 -7 5 |
| Initially treated with 150 mg Praluent 168 55 64.5 57 60 63 |
| |
| |
|(LONG TERM and HIGH FH) |
| Placebo 162 -1 4 |
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note: p<0.0001 vs. placebo for all data points

aPrimary efficacy endpoint

bLDL-C goal either 70 mg/dL or 100 mg/dL depending on baseline CV risk

cOn-treatment analysis (all other data are intention-to-treat)

dIncludes 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.

Visitwww.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for the full Prescribing Information

References

1 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.
2 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.
3 FH Foundation.What is FH? Available
from:http://thefhfoundation.org/about-fh/what-is-fh/Last accessed 6 August
2015.
4 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.
5 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.
6 Kastelein JJP, Farnier M, Hovingh GK, et al. Efficacy and safety of the
PCSK9 monoclonal antibody alirocu...

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