The U.S. Food and Drug Administration (FDA) approved Novo Nordisk's OZEMPIC (semaglutide) once-weekly injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D.

The approval was based on the results from eight Phase 3a clinical trials involving more than 8,000 T2D adults, including a two-year cardiovascular outcomes trial that evaluated safety in T2D adults at high risk of cardiovascular events. OZEMPIC brought clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release, and also resulted in body weight reductions. OZEMPIC approved for use in two therapeutic doses (0.5 mg and 1 mg), will be launched in the OZEMPIC pre-filled pen.

On December 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) also adopted a positive opinion, recommending the granting of a marketing authorization for OZEMPIC.

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