Sanofi announced today that the U.S. Food and Drug
Administration (FDA) approved Adlyxin (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
“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. The 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.
