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Sanofi receives FDA approval of Adlyxin TM for treatment of adults with Type 2 Diabetes

28 July 2016  •  Author: Sanofi

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved AdlyxinTM (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

Sanofi receives FDA approval of Adlyxin for treatment of adults with Type 2 Diabetes

“The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets,” said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. “We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”

The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA’s request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. T he most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.

Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily.

Adlyxin is approved under the proprietary name, Lyxumia ® in more than 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India . Adlyxin was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com

About Adlyxin

Adlyxin is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise . GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

4 responses to “Sanofi receives FDA approval of Adlyxin TM for treatment of adults with Type 2 Diabetes”

  1. DR.P.K.BHATTACHARYA says:

    I AM DELIGHTED TO KNOW THA WE HAVE NEW ARMS I OUR HAND TO FIGHT DIABETES AND I HAVE ALREADY STARTED TO USE TO MY PATIENTS MAINLY WHO ARE NOT RESPONDING WELL WITH CONVENTIONAL THERAPY. INSULIN REQUIREMENT DRASTICALLY REDUCED TO FEW OF MY PATIENTS. SALUTE TO SANOFI FOR HIS CONTINUOUS RESEARCH ON DIABETES MANAGEMENT AND ERADICATION

  2. Jim Coote says:

    The GetGoal publication did not mention any details of the dieting and exercise that was encouraged. It would be interesting to see whether there was any correlation between successful response to Adlyxin and these parameters. Any indications that greater levels of exercise or further improvements in diet might boost the response to Adlyxin still further, would have been particularly interesting.

  3. I HAVE NOT USED.I WANT DETAIL INFORMATION.

  4. kaiyoom says:

    more about Adlyxin

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