The United States Food and Drug Administration (FDA) has approved Denmark-based Novo Nordisk's Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type two diabetes that along with diet and exercise is intended to improve blood sugar (glucose), it was reported on Friday.
This product is claimed to be the first and only glucagon-like peptide-1 analogue in a pill and a new option for adults with type two diabetes who are not achieving their A1C goal with current antidiabetic treatment.
Approval has been given for the product based on results from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg. In the trials, the product decreased A1C and, as a secondary endpoint, showed decrease in body weight. The product is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg, and will be available in the US from the fourth quarter of 2019.
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