French-based pharmaceutical company Sanofi has received the US Food and Drug Administration (FDA) approval for Adlyxin (lixisenatide) injection to treat adult patients with type II diabetes.
Adlyxin is a once-daily, mealtime, Glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection that is used as an adjunct to diet and exercise in order to treat type II diabetes in adults, thereby improving their blood sugar (glucose) control.
Adlyxin is not insulin and not prescribed for use in place of long-acting insulin. The injectable drug should not be used on patients with type I diabetes or with diabetic ketoacidosis.
Sanofi global diabetes and cardiovascular business unit executive vice-president and head Peter Guenter said: “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.
“We are pleased with this approval as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”
Adlyxin will be available for the patients within a disposable pre-filled pen in a single dose of 20mg, as well as a single dose of 10mg, which should be initiated by the patients once a day for two weeks.
After taking the medicine for a fortnight, the patients will have to increase the dosage to 20mg once daily on the fifteenth day.
Under the proprietary name Lyxumia, Adlyxin is approved in more than 60 countries and marketed in more than 40 nations.
Adlyxin can cause serious side effects including the inflammation of the pancreas (pancreatitis), which may be severe and can also lead to death.