Public record
Evolocumab: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for evolocumab
The FDA label read for evolocumab (REPATHA, application BLA125522) was last revised on 2026-10-12. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-10-12 | |
| Label read | REPATHA | BLA125522, brand-name application |
| Boxed warning | No | |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient evolocumab from an original manufacturer
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Approvals
FDA approval history for evolocumab
The earliest FDA approval on file for a evolocumab product is 2015-08-27. Drugs@FDA lists 1 application for it and 20 approved supplements, the most recent on 2026-10-09.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 2015-08-27 | |
| Applications with an approval on file | 1 | |
| New drug applications (NDA) | 0 | |
| Generic applications (ANDA) | 0 | |
| Biologics applications (BLA) | 1 | |
| Approved supplements | 20 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-10-09 | |
| Sponsoring companies | 1 |
How this was calculated
Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.
Applications with a single-ingredient evolocumab product in Drugs@FDA, all sponsors and strengths
Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.
Medicare Part D
Medicare Part D spending on evolocumab
Medicare Part D spending on evolocumab products was $1.96B in 2024 across 2,245,760 claims, compared with $1.31B in 2023 (+49.9%). Average spending per claim was $874, before rebates.
| Measure | Value | Note |
|---|---|---|
| Total spending, 2024 | $1.96B | |
| Total spending, 2023 | $1.31B | |
| Change in spending, 2023 to 2024 | +49.9% | |
| Claims (prescription fills), 2024 | 2,245,760 | |
| Average spending per claim, 2024 | $874 | |
| Repatha Sureclick: spending, 2024 | $1.71B | 1,943,941 claims |
| Repatha Syringe: spending, 2024 | $196.0M | 233,776 claims |
| Repatha Pushtronex: spending, 2024 | $56.5M | 68,043 claims |
How this was calculated
Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.
Every single-ingredient evolocumab product in Part D (Repatha Sureclick, Repatha Syringe, Repatha Pushtronex), 2024.
Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.
Pharmacy cost
Pharmacy acquisition cost (NADAC) for evolocumab
Retail pharmacies paid an average of $282.01 per mL for REPATHA 140 MG/ML SURECLICK as of 2026-11-11, compared with $276.43 twelve months earlier (+2.0%). This is a pharmacy purchase cost, not a patient price.
| Measure | Value | Note |
|---|---|---|
| REPATHA 140 MG/ML SURECLICK, now | $282.01 per mL | |
| REPATHA 140 MG/ML SURECLICK, 12 months earlier | $276.43 per mL | |
| Change over 12 months | +2.0% | |
| REPATHA 140 MG/ML SYRINGE | $281.81 per mL | 12 months earlier $275.95 (+2.1%) |
How this was calculated
Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.
Brand-name product of evolocumab in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12
NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.
Adverse event reports
Most reported events in FDA adverse event reports for evolocumab
Through 2026-10-28, FDA had received 165,247 adverse event reports for evolocumab, 28,865 of them marked serious by the reporter. The symptom terms named most often were injection site pain (11,254), back pain (5,658) and myalgia (5,487).
| Measure | Value | Note |
|---|---|---|
| All reports received | 165,247 | |
| Reports the reporter marked serious | 28,865 | death, hospitalisation, disability or similar outcome |
| Injection site pain | 11,254 reports | |
| Back pain | 5,658 reports | |
| Myalgia | 5,487 reports | |
| Injection site bruising | 4,954 reports | |
| Fatigue | 4,163 reports |
How this was calculated
Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example device difficult to use) were left out of the list.
Reports where FDA recorded evolocumab as a single-ingredient active substance (any brand), all years to 2026-10-28
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Clinical studies
Registered clinical studies of evolocumab
ClinicalTrials.gov lists 165 registered studies that name evolocumab as an intervention as of 2026-11-11. Of these, 15 are recruiting, 82 are completed and 43 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 165 |
| Recruiting now | 15 |
| Not yet recruiting | 10 |
| Completed | 82 |
| Terminated, withdrawn or suspended | 19 |
| Phase 3 (including phase 2/3) | 43 |
| Phase 2 (including phase 1/2) | 25 |
| Phase 1 | 10 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches evolocumab, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
Articles on Evolocumab
- Repatha (Evolocumab) Missed-Dose Protocol: What to Do and When
- Repatha (Evolocumab) Pharmacokinetics: Absorption, Distribution, Metabolism, and Elimination
- Repatha (Evolocumab) Adult Dosing for Ages 30 to 49: Schedule, Administration, and What to Expect
- Repatha Cancer Risk Signal Review: What the Evidence Actually Shows
- Does Medicare Advantage Cover Repatha (Evolocumab)?
- Repatha Mental Health and Mood Impact: What the Evidence Actually Shows