US FDA approves first GLP-1 oral drug to protect against heart attacks, stroke

PTC News Desk: The US Food and Drug Administration (FDA) has approved the first oral GLP-1 receptor agonist, Rybelsus (semaglutide), to help prevent heart attack and stroke in adults with type 2 diabetes and high cardiovascular risk.

The approval represents a significant broadening of Rybelsus’s use. Initially approved in 2019 for controlling blood sugar, the drug can now, based on new findings from the SOUL trial, be prescribed to lower the risk of major adverse cardiovascular events (MACE)—including cardiovascular death, nonfatal heart attack, and nonfatal stroke—even in patients without a prior history of such events.