Industry/Regulatory Developments
A cardiovascular trial result does not rewrite the label by itself
SELECT showed a cardiovascular difference with semaglutide 2.4 mg in a defined population. Whether a prescribing label states that use is a separate document.
SELECT is a trial. A prescribing label is an agency document. The 2021 Wegovy label for semaglutide describes an approved obesity use. It is not the SELECT paper, and a PDF from 2021 cannot be assumed to contain every later indication. Labels are revised. If you need to know whether a cardiovascular outcome is now part of the indication, open the current label, not a recollection of it.
What SELECT itself can support
It can support sentences about weekly semaglutide 2.4 mg, against placebo, in adults with cardiovascular disease and overweight or obesity and without diabetes, followed for a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The hazard ratio was 0.80. Discontinuation for adverse events was higher on semaglutide. That is the trial.
What it cannot support
It cannot support a claim about a different dose, a diabetes population, or a research chemical that was not the randomized product. FLOW is the kidney trial at 1 mg, and it has its own paper. The regulatory habit is to keep the trial, the registry NCT03574597, and the current label as three citations, and not to let one of them speak for the other two.