Health Canada approves expanded indication for SOLIQUA®

    --  New indication for SOLIQUA(®) offers an alternative approach for
        Canadians living with type 2 diabetes requiring treatment
        intensification
    --  From the makers of Lantus(®), the efficacy, safety, and convenient
        once-daily administration schedule of SOLIQUA(®) provides a new
        treatment option for Canadians with type 2 diabetes

LAVAL, QC, Dec. 18, 2020 /CNW Telbec/ - Sanofi Canada announced that Health Canada has approved expanded use of SOLIQUA(®). The once-daily injection, is now indicated in combination with metformin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin or a glucagon-like peptide-1 receptor agonist (GLP-1RA) in combination with metformin.

Approximately one in three Canadians lives with diabetes.(1 )Achieving optimal blood glucose control is fundamental to the management of diabetes. Therapy in most individuals with type 2 diabetes should be targeted to achieve an average three-month blood glucose level (A1C) <=7.0%.

"At Sanofi, we're proud to continue to bring innovation to the diabetes community," said Sabina Steinkellner, General Manager, General Medicines, Sanofi Canada. "With this approval from Health Canada, we believe that SOLIQUA provides a valuable new option to physicians and patients as they look to achieve their treatment goals."

SOLIQUA(®), which combines Lantus(®) (insulin glargine injection) 100 Units/mL, and Adlyxine(®) (lixisenatide injection), works together to help lower A1c for patients with type 2 diabetes (T2D).

About the LixiLan-G study

The primary objective of the LixiLan-G study was to demonstrate superior reduction of HbA1c with SOLIQUA versus continuation of the previous GLP-1 RA after 26 weeks. Secondary objectives included comparison of the overall efficacy and safety of SOLIQUA to continued GLP-1 RA treatment.

About SOLIQUA(®)

SOLIQUA(®) is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

The treatment is a titratable fixed-ratio combination that shows improved efficacy and comparable or improved safety outcomes relative to its separate constituents, offering an alternative approach to intensification of therapy in T2D.(2)

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi entities in Canada employ approximately 2,000 people. In 2018, we invested more than $127 million in R&D in Canada, creating jobs, business and opportunity throughout the country.

Follow us on Twitter @SanofiCanada and on YouTube.

Sanofi, Empowering Life



     
     References





     
     (1)        Diabetes Canada. https://
                     www.diabetes.ca/media-
                     room/press-releases/one-
                     in-three-canadians-is-
                     living-with-diabetes-or-
                     prediabetes,-yet-
                     knowledge-of-risk-and-
                     complicatio. Accessed
                     November 16, 2020.



     
     (2)        (Ref: Goldman J, Trujillo JM.
                     iGlarLixi: A Fixed-Ratio
                     Combination of Insulin
                     Glargine 100 U/mL and
                     Lixisenatide for the
                     Treatment of Type 2
                     Diabetes. Ann Pharmacother.
                     2017 Nov;51(11):990-999.
                     doi: 10.1177/
                     1060028017717281. Epub 2017
                     Jun 23. PMID: 28645216.)

SOURCE Sanofi-Aventis Canada Inc.