FDA Approves Higher Dose of Ozempic
The FDA has approved a 2 mg dose of Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog to improve blood sugar in adults with type 2 diabetes. Ozempic is now available in three doses (0.5 mg, 1 mg, and 2 mg) to help people with type 2 diabetes reach their blood sugar goals.
The approval is based on the phase 3 SUSTAIN FORTE trial, which found the higher dose of Ozempic helped patients who needed additional glycemic control. In the trial, people with an average starting A1c of 8.9% treated with Ozempic 2 mg achieved a reduction in A1c of 2.1% at week 40 compared with 1.9% with Ozempic 1 mg.
In the previous phase 3 SUSTAIN trial, up to 73% of people with type 2 diabetes treated with the 1 mg dose lowered their blood sugar and reached the American Diabetes Association target of <7%.
With the higher dose, the most common adverse events were gastrointestinal. Gastrointestinal adverse reactions occurred more frequently among patients receiving Ozempic 2 mg (34.0%) vs Ozempic 1 mg (30.8%).
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