Full Press Release Details
Sanofi Announces Soliqua 100/33 Now Available in the U.S.
Paris, France January 4, 2017 Sanofi announced today that Soliqua 100/33 (insulin
glargine 100 Units/mL & lixisenatide* 33 mcg/mL injection) is now available by prescription in U.S. pharmacies. Soliqua 100/33 is indicated for the treatment of adults with type 2
diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.
We are encouraged by
the potential of Soliqua 100/33, which has demonstrated superior HbA1c lowering versus Lantus, said Peter Guenter, Executive Vice President, Head,
Global Diabetes & Cardiovascular Business Unit, Sanofi. By offering Soliqua 100/33 a product containing both a basal insulin and
a GLP-1 therapy at a competitive price while facilitating patient access, we believe we
are providing value to patients and the healthcare system.
In the labeled clinical
trial, once-daily Soliqua 100/33 demonstrated statistical superiority for the change in HbA1c from baseline to week 30 (p<0.0001) versus Lantus , the most prescribed basal insulin in the
world.1,2,3 The most common side effects reported in the clinical program included low blood sugar, nausea, stuffy or runny nose and sore throat, diarrhea, upper respiratory tract infection and
headache. Soliqua 100/33 is delivered in a single pre-filled SoloStar pen with a dose range covering from 15 to 60 Units and two starting doses to support patients insulin needs. Soliqua 100/33 was
approved by the U.S. Food and Drug Administration (FDA) on November 21, 2016.
The daily Wholesale Acquisition Cost (WAC) price of Soliqua 100/33 is
$127 for a 300 Unit pen, which equals $19.90 per day at the average final dose of 47 Units used in the labeled clinical trial.
Sanofi is offering Soliqua
100/33 at a $0 co-pay** for eligible U.S. patients with commercial insurance and is working to secure coverage for Soliqua 100/33 on health plans
nationwide. Sanofi is also offering a tailored support program, Soliqua 100/33 COACH, at no cost to adults living with type 2 diabetes who have been prescribed Soliqua 100/33 by their doctor. For additional information, please visit www.soliqua100-33.com.
Healthcare professionals need a broad range of treatments to individualize a
patient s diabetes care, particularly for the many adults living with diabetes who continue to face challenges in controlling their blood sugar levels even after treatment with basal insulin, said George Grunberger, M.D., FACP, FACE,
Chairman, Grunberger Diabetes Institute. This combination product provides a new option for many patients uncontrolled on basal insulin therapy or lixisenatide.
What is SOLIQUATM 100/33 (insulin glargine 100 Units/mL and lixisenatide 33 mcg/mL injection)?
SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine 100 Units/mL and lixisenatide, that may
improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or lixisenatide.
Important Safety Information for SOLIQUATM 100/33 (insulin glargine and lixisenatide injection) 100
Units/mL and 33 mcg/mL
What is the most important information I should know about SOLIQUA 100/33?
Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed.
SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas, which may be life-threatening.
Before using SOLIQUA 100/33, tell your doctor if you have had:
These medical problems may make you more likely to get pancreatitis. Stop taking SOLIQUA 100/33 and call your healthcare
provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.
Who should not use SOLIQUA 100/33?
100/33 if you are having an episode of low blood sugar (hypoglycemia) or if you are allergic to insulin glargine, lixisenatide, or any of the other ingredients in SOLIQUA 100/33.
Tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including all
prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may affect the way some medicines work
How should I use SOLIQUA 100/33?
SOLIQUA 100/33 may cause serious side effects, including:
| headache | dizziness | drowsiness | confusion | |||
| weakness | irritability | hunger | sweating | |||
| fast heartbeat | feeling jittery |
The most common side effects of SOLIQUA 100/33 may include:
| low blood sugar (hypoglycemia) | allergic reactions | |
| nausea | diarrhea | |
| headache | upper respiratory tract infection | |
| stuffy or runny nose and sore throat |
Nausea and diarrhea usually happen more often when you start using SOLIQUA 100/33.
Please click here for full Prescribing Information for SOLIQUA 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL:
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio
evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated
solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders
in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused on patients needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and
Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product.
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quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or
identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofi s annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
| Global Media Relations Jack Cox Tel.: + (33) 1 53 77 46 46 mr@sanofi.com | Investor Relations George Grofik Tel.: + (33) 1 53 77 45 45 ir@sanofi.com | |
| U.S. Media Relations Ashleigh Koss Tel.: +1 (908) 981-8745 ashleigh.koss@sanofi.com | U.S. Diabetes Communications Susan Brooks Tel.: +1 (908) 981 6566 susan.brooks@sanofi.com | |
| Global Diabetes Communications Philip McNamara Tel.: +1 (908) 938 0390 philip.mcnamara@sanofi.com |