# AMGEN INC: efficacy supplement approved for REPATHA

**Score:** 75/100

| Field | Value |
|---|---|
| Sponsor | AMGEN INC |
| Product | REPATHA |
| Generic / ingredient | EVOLOCUMAB |
| Approval | Drug efficacy supplement (new indication or use) |
| Application | BLA125522 supplement 47 |
| Decided | 2026-10-09 |
| Panel / class | INJECTABLE, INJECTION |

## Why this score
- Decided in the last 30 days.
- New indication or use: a relaunch.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125522). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.