Novo's semaglutide passes sixth Phase III test

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said subcutaneous semaglutide ( NN9535) significantly reduced cardiovascular risk vs. placebo in the Phase IIIa SUSTAIN 6 trial to treat Type II diabetes. It also met the study's primary endpoint of non-inferiority to placebo at reducing risk of major adverse cardiovascular events. Novo expects to submit regulatory applications for the candidate in the U.S. and EU in 4Q16.

The 3,300-patient, 104-week trial studied once weekly 0.5 mg or 1 mg semaglutide or placebo in addition to standard of care. The study's composite primary endpoint included first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. ...