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ODYSSEY Program
The ODYSSEY Phase 3 program is one of the most comprehensive clinical trial programs ever conducted for
an investigational LDL cholesterol lowering therapy. The program includes 14 global Phase 3 trials evaluating
more than 23,500 patients. The primary efficacy end point in all of the studies was the mean percent reduction
from baseline in LDL cholesterol at week 24 compared to placebo (maximally tolerated statin therapy); all of
the completed studies met their primary endpoint. A significantly higher proportion of patients achieved LDL
cholesterol of less than 70 mg/dL in the Praluent group as compared to placebo at both week 12 and week 24.
The ongoing ODYSSEY OUTCOMES trial will prospectively evaluate the cardiovascular benefits of Praluent
in approximately 18,000 patients.
Important Safety Information
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.
www.fda.gov/medwatch or call 1-800-FDA-1088
Please click here for the full Prescribing Information.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the
new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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