Novo to seek semaglutide approvals on new CVOT data

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) said it will submit regulatory applications next half in the U.S. and EU for once-daily oral semaglutide after reporting the compound met the primary endpoint in the Phase IIIa PIONEER 6 cardiovascular outcomes trial (CVOT) in Type II diabetics. The company also hopes it can use data from PIONEER 6 to support a CV indication for Ozempic, its marketed once-weekly subcutaneous formulation of semaglutide.

On the primary endpoint of PIONEER 6, 14 mg oral semaglutide plus standard of care (SOC) was non-inferior to placebo plus SOC in reducing major adverse CV events (MACE) (HR=0.79). MACE was defined as the first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke...