Novo’s semaglutide injection and tablets get expanded FDA approval for type 2 diabetes with established CVD

pharmafile | January 17, 2020 | News story | Medical Communications, Sales and Marketing |  FDA, Novo Nordisk, Ozempic, cardiovascular disease, diabetes, pharma 

Novo Nordisk has seen label expansions approved from the FDA for both its glucagon-like peptide-1 (GLP-1) analogue injection Ozempic (once-weekly semaglutide) and its GLP-1 oral tablet Rybelsus (oral semaglutide).

The expansions are indicated for the reduction of the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adult type 2 diabetes patients with established cardiovascular disease (CVD).

With Ozempic, supporting data demonstrated that the drug generated a “statistically significant” reduction in the risk of cardiovascular death, proving 26% more effective than placebo when used in combination with standard of care.

With Rybelsus, data from a separate study showed that the drug proved non-inferior with regards to safety in the composite MACE endpoint. 3.8% of Rybelsus patients experienced at least one MACE, compared to 4.8% with placebo.

“We strongly believe in the benefits of semaglutide and this approval marks an important milestone. Ozempic now offers people in the US with type 2 diabetes and established cardiovascular disease an effective treatment option to both lower their blood glucose and reduce their cardiovascular risk,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk. “We also appreciate that the results from the PIONEER 6 study are reflected in the label for Rybelsus and to further evaluate the cardiovascular risk reduction profile we are currently conducting the cardiovascular outcomes trial, SOUL.”

Matt Fellows