EU label update: oral semaglutide first oral GLP-1RA with proven CV benefit
Oral semaglutide has been approved in the EU to reduce the risk of MACE in adults with T2D at high cardiovascular risk, following results from the SOUL trial.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved a label update for oral semaglutide (Rybelsus®) to reduce the risk of cardiovascular death, MI and stroke in adults with T2D at high cardiovascular risk. This approval was based on the results from the SOUL trial.
SOUL was a multicenter, placebo-controlled, double-blind, phase 3 trial in which 9,650 adults with T2D and ASCVD and/or CKD were randomized to once-daily oral semaglutide or placebo on top of standard of care. In SOUL, oral semaglutide reduced the risk of MACE - a composite of cardiovascular death, MI, and stroke - by 14% compared with placebo.
Oral semaglutide is now the only oral GLP-1RA in the EU with proven cardiovascular benefit. A decision by the FDA in the US is expected later this year.