Oral semaglutide gets new indication from FDA
The medication is now indicated to reduce the risk of major adverse cardiovascular events such as cardiovascular death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events.
An expanded FDA approval of oral semaglutide (Rybelsus) tablets, 7 mg or 14 mg, was recently announced by the manufacturer, Novo Nordisk. The medication is now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as cardiovascular death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events.
The announcement cited the results of the SOUL trial, published by the New England Journal of Medicine in March, in which oral semaglutide demonstrated a statistically significant 14% relative reduction in risk of MACE at four years compared with placebo. The most common serious adverse events were cardiac disorders and infections/infestations.