Novo Nordisk has submitted 2 New Drug Applications (NDAs) for oral semaglutide as well as a supplemental NDA (sNDA) for subcutaneous (SC) semaglutide (glucagon-like peptide-1; Ozempic).
The first NDA for oral semaglutide is seeking approval for the treatment of adults with type 2 diabetes (T2D). The submission includes data from 10 PIONEER clinical trials, enrolling 9543 adults with type 2 diabetes. The data showed patients who received oral semaglutide had greater blood glucose reductions vs sitagliptin, empagliflozin, liraglutide, and placebo. Treatment with oral semaglutide also led to greater reductions in mean body weight vs most comparators.
The second NDA for oral semaglutide is seeking an indication of cardiovascular (CV) risk reduction in adults with T2D. If oral semaglutide is approved, it would become the first oral GLP-1 receptor agonist to be available in tablet form.
The sNDA for Ozempic – currently approved as a SC injection to improve glycemic control in T2D patients – is also seeking a CV risk reduction in T2D patients.
The oral semaglutide NDA for the treatment of T2D has been granted Priority Review, meaning a shorter anticipated review time of 6 months from the submission date. The Company is anticipating a 10-month review time for the other 2 submissions; these are accompanied by data from 2 CV outcomes trials, PIONEER 6 (for oral semaglutide) and SUSTAIN 6 (for Ozempic), which looked at the effects of adding semaglutide or placebo to standard of care on the risk of CV events.
“We are excited about the regulatory filings of the first GLP-1 receptor agonist in a tablet, as we believe oral semaglutide has the potential to further improve the treatment of adults living with type 2 diabetes,” stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
For more information visit NovoNordisk.com.