Biotech Values

[DewDiligence]

NVO—Ozempic trial_in CKD meets_efficacy_threshold_for_early stopping:

https://www.globenewswire.com/news-release/2023/10/10/2757941/0/en/Novo-Nordisk-will-stop-the-once-weekly-injectable-semaglutide-kidney-outcomes-trial-FLOW-based-on-interim-analysis.html

NVO does not yet have the actual data, but we may presume that the efficacy threshold for stopping this kind of trial at an interim analysis is very high.

The trial in question, called FLOW, tested Ozempic 1.0mg/wk vs placebo in patients with T2D and CKD. The primary endpoint was time to the earliest of the following events:

• >=50% reduction in persistent eGFR relative to baseline

• Persistent eGFR <15

• Start of dialysis

• Kidney transplant

• Death from kidney disease or cardiovascular disease