Adlyxin (lixisenatide) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes in adults, the agency said Thursday in a news release.
As the FDA explained, Adlyxin is a “glucagon-like peptide-1 receptor agonist” — a hormonal drug that helps control blood sugar. The drug was evaluated in clinical studies involving 5,400 people with type 2 diabetes. A separate study was held involving 6,000 type 2 diabetics at risk for atherosclerotic cardiovascular disease, the FDA said.
Type 2 diabetes affects more than 29 million people in the United States, accounting for about 90 percent of diagnosed cases of diabetes, the agency said. Elevated blood sugar caused by the disease can lead to complications including heart disease, blindness and nerve and kidney damage.
The most common side effects of Adlyxin included nausea, vomiting, headache, diarrhea and dizziness. Low blood sugar (hypoglycemia) was an adverse reaction among people who took Adlyxin in tandem with other antidiabetic medications, the FDA said. Severe allergic-like reactions also were reported during clinical evaluations of the drug.
The agency said it had ordered post-marketing studies of Adlyxin to evaluate its safety among children, and to focus on the body’s immune response to the drug.
Adlyxin is produced by Sanofi-Aventis, based in Bridgewater, N.J.
Learn more about this approval from the FDA.