New diabetes drug up against leading brands

FDA approved lixisenatide (Adlyxin, Sanofi-Aventis), a once-daily mealtime GLP-1 receptor agonist injection for type 2 diabetes, which will compete against the once-weekly pen dulaglutide (Trulicity, Eli Lilly) and the injectable liraglutide (Victoza, Novo Nordisk).

Even though Adlyxin is approved under the proprietary name Lyxumia in more than 60 countries, it faces tough competition in the U.S. Trulicity, Victoza and other brands have already gained a foothold with U.S. physicians. Plus, Victoza studies show that the drug significantly reduced the combined incidence of heart attack, stroke and cardiovascular death in high-risk Type 2 diabetes patients.

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Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable, pre-filled pen in a single dose of 10 mcg. that they should initiate once daily for 14 days.  On Day 15, patients will increase dosage to 20 mcg. once daily.

The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin.

Use of Adlyxin improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials.

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In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo in a cardiovascular outcomes trial. Use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.

Adlyxin should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).

The most common side effects associated with Adlyxin include nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Adlyxin and other antidiabetic drugs such as sulfonylurea and/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials of Adlyxin.

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