Posted by Michael Wonder on 20 Mar 2019
Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic
20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for oral semaglutide, a once-daily glucagon-like peptide-1 analogue in a tablet, as well as a supplemental new drug application for once-weekly Ozempic (semaglutide).
An application was submitted for oral semaglutide seeking approval for an indication for the treatment of adults with type 2 diabetes. A priority review voucher has been applied to the application, leading to an anticipated review time of six months from the submission date, according to standard FDA review timelines.
The submission for oral semaglutide for the treatment of glycaemic control in adults with type 2 diabetes is based on the results from 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes.
