FDA Approves Adlyxin for Type 2 Diabetes Mellitus
Once-daily injection to improve glycemic control, along with diet and exercise
THURSDAY, July 28, 2016 (HealthDay News) -- Adlyxin (lixisenatide), a glucagon-like peptide-1 receptor agonist, 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.
Adlyxin was evaluated in clinical studies involving 5,400 patients with type 2 diabetes. A separate study was held involving more than 6,000 type 2 diabetes patients at risk for atherosclerotic cardiovascular disease, the FDA said.
The most common side effects of Adlyxin included nausea, vomiting, headache, diarrhea, and dizziness. Hypoglycemia was an adverse reaction among patients 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 is requiring post-marketing studies to evaluate the safety of Adlyxin among children, and to focus on its immunogenicity.
Adlyxin is produced by Sanofi-Aventis U.S. LLC, based in Bridgewater, N.J.