Public record

Evolocumab: the public record

6 tables from US federal sources. Latest data date: Nov 11, 2026.

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.

FDA label facts for evolocumab: the figures
MeasureValueNote
Label revision date2026-10-12
Label readREPATHABLA125522, brand-name application
Boxed warningNo
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

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.

Scope: 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.

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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.

FDA approval history for evolocumab: the figures
MeasureValueNote
Earliest FDA approval on file2015-08-27
Applications with an approval on file1
New drug applications (NDA)0
Generic applications (ANDA)0
Biologics applications (BLA)1
Approved supplements20label, manufacturing and efficacy changes
Most recent supplement approval2026-10-09
Sponsoring companies1

Source: FDA, Drugs@FDA, data as of Nov 11, 2026

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.

Scope: 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.

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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.

Medicare Part D spending on evolocumab: the figures
MeasureValueNote
Total spending, 2024$1.96B
Total spending, 2023$1.31B
Change in spending, 2023 to 2024+49.9%
Claims (prescription fills), 20242,245,760
Average spending per claim, 2024$874
Repatha Sureclick: spending, 2024$1.71B1,943,941 claims
Repatha Syringe: spending, 2024$196.0M233,776 claims
Repatha Pushtronex: spending, 2024$56.5M68,043 claims

Source: CMS, Medicare Part D Spending by Drug, data as of 2024

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.

Scope: 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.

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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.

Pharmacy acquisition cost (NADAC) for evolocumab: the figures
MeasureValueNote
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 mL12 months earlier $275.95 (+2.1%)

Source: CMS, National Average Drug Acquisition Cost (NADAC), data as of Nov 11, 2026

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.

Scope: 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.

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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).

Most reported events in FDA adverse event reports for evolocumab: the figures
MeasureValueNote
All reports received165,247
Reports the reporter marked serious28,865death, hospitalisation, disability or similar outcome
Injection site pain11,254 reports
Back pain5,658 reports
Myalgia5,487 reports
Injection site bruising4,954 reports
Fatigue4,163 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

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.

Scope: 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.

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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.

Registered clinical studies of evolocumab: the figures
MeasureValue
Registered studies165
Recruiting now15
Not yet recruiting10
Completed82
Terminated, withdrawn or suspended19
Phase 3 (including phase 2/3)43
Phase 2 (including phase 1/2)25
Phase 110

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

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.

Scope: 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.

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Articles on Evolocumab