Repatha (evolocumab) - cardiovascular risk reduction label expansion (VESALIUS-CV) was approved by the FDA on October 9, 2026 for to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, unstable angina requiring hospitalization, coronary revascularization, or any ischemia-driven arterial revascularization) in adults at increased risk for these events; label now includes the VESALIUS-CV trial in patients without a prior myocardial infarction or stroke.
The FDA approved an efficacy supplement for Repatha (evolocumab) on October 9, 2026 that revises the cardiovascular risk-reduction indication and adds the VESALIUS-CV trial, in adults without a prior heart attack or stroke, to the label (BLA 125522, supplement 47). As of October 14, 2026 Amgen had not issued a release on it.
The FDA's approval letter for BLA 125522 supplement 47 is dated October 9, 2026 and describes labeling modifications based on VESALIUS-CV (trial 20170625) and a revised indication to reduce the risk of major adverse cardiovascular events, including any ischemia-driven arterial revascularization, in adults at increased risk for these events (FDA approval letter; revised label). This page is dated by the FDA's action; Amgen's investor site listed no release on this approval as of October 14, 2026. pdufa.bio did not hold a goal date for this supplement, so no early or late margin is computed.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, BLA 125522 supplement 47, October 9, 2026
FDA record of the action: the FDA approved on October 9, 2026, per BLA 125522 SUPPL-47 (Drugs@FDA). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Repatha (evolocumab) on October 9, 2026, per the FDA's own record. The primary source is linked on this page.
Repatha (evolocumab) is an Amgen (AMGN) program. The FDA decision came on October 9, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), AMGN moved +16.4%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.