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2.38 MB
Extraction Summary
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Document Information
Type:
Corporate communication / product information sheet
File Size:
2.38 MB
Summary
This document is a corporate communication and product information sheet for the prescription drug Praluent (alirocumab), manufactured by Sanofi. It details the ODYSSEY clinical trial program, provides important safety information for patients, and includes a legal disclaimer. The document is marked with the identifier 'HOUSE_OVERSIGHT_026366' but contains no information whatsoever related to Jeffrey Epstein, his associates, finances, or travel.
Organizations (6)
| Name | Type | Context |
|---|---|---|
| Sanofi |
An integrated global healthcare company that discovers, develops, and distributes therapeutic solutions, including Pr...
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| Genzyme |
Mentioned as one of Sanofi's growth platforms ('the new Genzyme').
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| FDA (Food and Drug Administration) |
The U.S. agency to which negative side effects of prescription drugs should be reported via www.fda.gov/medwatch or 1...
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| EURONEXT |
The Paris stock exchange where Sanofi is listed under the ticker SAN.
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| NYSE (New York Stock Exchange) |
The New York stock exchange where Sanofi is listed under the ticker SNY.
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| HOUSE_OVERSIGHT |
Appears as a Bates number or document identifier ('HOUSE_OVERSIGHT_026366') in the footer, suggesting the document wa...
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Timeline (2 events)
Not specified
ODYSSEY Phase 3 program: A large-scale clinical trial program for the investigational LDL cholesterol-lowering therapy, Praluent (alirocumab), involving over 23,500 patients in 14 global trials.
Global
23,500+ patients
Ongoing (at time of writing)
ODYSSEY OUTCOMES trial: An ongoing trial to evaluate the cardiovascular benefits of Praluent in approximately 18,000 patients.
Not specified
18,000 patients
Key Quotes (3)
"The information contained in this communication is confidential, may be attorney-client privileged, may constitute inside information, and is intended only for the use of the addressee. It is the property of"Source
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Quote #1
"Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT."Source
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"HOUSE_OVERSIGHT_026366"Source
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Full Extracted Text
Complete text extracted from the document (3,041 characters)
UK: +44 (0) 203 107 0289
U.S.: +1 888 660 6127
Access code: 81662098
U.S.: +1 888 660 6127
Access code: 81662098
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.
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.
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.
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).
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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please note
The information contained in this communication is
confidential, may be attorney-client privileged, may
constitute inside information, and is intended only for
the use of the addressee. It is the property of
please note
The information contained in this communication is
confidential, may be attorney-client privileged, may
constitute inside information, and is intended only for
the use of the addressee. It is the property of
HOUSE_OVERSIGHT_026366
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