FDA Approves Adlyxin for Type 2 Diabetes Mellitus

Share this content:
FDA Approves Adlyxin for Type 2 Diabetes Mellitus
FDA Approves Adlyxin for Type 2 Diabetes Mellitus

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.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

CDC: Influenza Vaccine 48 Percent Effective Overall

CDC: Influenza Vaccine 48 Percent Effective Overall

More severe H3N2 strain a factor in reduced coverage

D.C. Zika Tests Were Flawed

D.C. Zika Tests Were Flawed

One of the issues with tests was a mathematical error

Experts Warn of Health Threats From Climate Change

Experts Warn of Health Threats From Climate Change

Additional 250,000 deaths/year projected from heat stress, malnutrition, infectious diseases

is free, fast, and customized just for you!

Already a member?

Sign In Now »