The U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide) as a new treatment for type 2 diabetes this week. The treatment consists of a daily injection that, combined with diet and exercise, can control blood sugar levels in adults with this common type of diabetes.
Adlyxin is a glucagon-like peptide-1 receptor agonist, a hormone that stimulates the production of insulin to promote the normalization of sugar levels in the blood. However, Adlyxin is not insulin, and should not be used to treat type 1 diabetics or people with diabetic ketoacidosis.
“The FDA continues to support the development of new drug therapies for diabetes management,” Mary Thanh Hai Parks, MD, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”
The safety and efficacy of Adlyxin were evaluated in several clinical trials involving 5,400 people with type 2 diabetes (the GetGoal clinical program), and in a separate study with 6,000 type 2 diabetics at risk for atherosclerotic cardiovascular disease. The trials showed that treatment with Adlyxin, both as a monotherapy or in combination with other FDA-aproved diabetes medications, improved the levels of A1c (a measure of the average blood sugar levels). Adlyxin was also found to not increase the risk of cardiovascular adverse effects in at-risk patients in the separate study.
Concerning safety, the most common side effects of Adlyxin included headache, dizziness, nausea, vomiting, and diarrhea. Low blood sugar (hypoglycemia) was also observed in patients treated simultaneously with Adlyxin and other diabetes drugs. Severe allergic reactions were also reported during the clinical evaluation of the drug.
It is not yet known whether Adlyxin is safe and effective in children, or how the body’s immune system responds to the drug, and the FDA requested post-marketing studies to address these two issues.
Adlyxin will be available in disposable pre-filled pens with 10 and 20 micrograms. Patients begin treatment with a dose of 10 micrograms each day for 14 days, increasing the daily dose to 20 micrograms on day 15 and each day thereafter.
Adlyxin is produced by Sanofi, based in Bridgewater, N.J., and is already marketed under the name Lyxumia in more than 40 countries, including those of the European Union, Brazil and Japan, Sanofi said in a press release.
Type 2 diabetes affects 90% of the patients diagnosed with diabetes in the U.S., and is characterized by increased levels of blood sugar due to insulin resistance. This can lead to complications such as blindness, heart disease, and nerve and kidney damage.