FDA Approves Adlyxin For Type 2 Treatment

In a recent press announcement, the U.S. Food and Drug Administration (FDA) officially declared that Adlyxin (lixisenatide) has been approved to treat people with type 2 diabetes.

The announcement is part of the FDA's efforts “to support the development of new drug therapies for diabetes management,” according to deputy director Mary Thanh Hai Parks, M.D. The administration is optimistic that this new drug will be influential in treating the over 29 million people affected by type 2 diabetes in the United States

About Adlyxin

Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist – in other words, a hormone that controls blood sugar. Patients will take the drug through a daily injection, which will be available in disposable pens of either 10 or 20 micrograms.

Some Tips For Safety

The FDA explained that the drug had been evaluated for safety and efficacy via two separate studies involving 5,400 and 6,000 type 2 diabetics, respectively. Through these studies, they found that the most common side effects were “nausea, vomiting, headache, diarrhea, and dizziness.” Those who took Adlyxin along with other antidiabetic medications were also subject to hypoglycemia, and some patients did experience “allergic-like reactions.”

The FDA also encouraged people not to take Adlyxin if they were experiencing increased ketones in their blood or urine. They also require follow-up studies before they will determine whether or not Adlyxin is safe for pediatric patients.

Adlyxin's developer, French pharmaceutical company Sanofi, were understandably grateful to get the approval. “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,” Executive Vice President and Head of Sanofi's Global Diabetes & Cardiovascular Business Unit, Peter Guenter, said in a press release. “We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”