用于多发性神经病WAINUA(eplontersen)产品质量审评（FDA）

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CENTER FOR DRUG EVALUATIONAND

RESEARCH

APPLICATIONNUMBER:

217388Orig1s000

PRODUCT QUALITY REVIEW(S)

Center for Drug Evaluation and Research

Office of Pharmaceutical Quality

NDA Executive Summary

1.Application/Product Information

NDA Number

217388

Applicant Name

lonis Inc.

Drug Product Name

TRADENAME(eplontersen)

Dosage Form

Injection

Proposed Strength(s)

45 mg/0.8 mL

Route of Administration

Subcutaneous

Maximum Daily Dose

45 mg administered once monthly

Rx/OTC Dispensed

Proposed Indication

Treatment of the polyneuropathy of hereditary

transthyretin mediated amyloidosis(ATTRv)in adults

Drug Product Description

clear,colorless-to-yellow solution in a single-dose

autoinjector

Co-packaged product

information

N/A

Device information

N/A

Storage Temperature/

Conditions

(b)(4)

(b)(4)Refrigerate,2℃ to 8℃.Patient/caregiver

may store at up to 30℃/6 weeks if needed.

Review Team

Discipline

Primary

Secondary

Drug Substance

Katherine Duncan

Donna Christner

Drug Product

Jizhou Wang

Martha Heimann

Labeling

Jizhou Wang

Martha Heimann

Manufacturing

Raeann Wu

Cassandra

Abellard

Biopharmaceutics

N/A

Microbiology

Helen Ngai

Elizabeth Bearr

Page 1 of 3

Reference ID:5232776

Center for Drug Evaluation and Research

Office of Pharmaceutical Quality

Reference ID:5232776

Environmental:

N/A

RBPM

Erica Keafer

ATL

Martha Heimann

Consults

Alan Stevens(CDRH/OPEQ)reviewed device aspects of

the product (autoinjector and syringe).His review,dated

8/22/2023,recommends approval of the application.

2.Final Overall Recommendation -Approval

3.Action Letter Information

a.Expiration Dating:

24 months when stored refrigerated,2℃to 8℃.

b.Additional Comments for Action

There are no additional comments for the action letter.

4.Basis for Recommendation:

a.Summary of Rationale for Recommendation:

The Office of Pharmaceutical Quality (OPQ)recommends APPROVAL of NDA

217388 for TRADENAME(eplontersen injection).Based on our evaluation of the

available information,the applicant provided sufficient information to support an

approval recommendation from the product quality perspective.The applicant

provided adequate information to ensure the identity,strength,purity,and

strength of the proposed drug product.The overall manufacturing inspection

recommendation is approval for allthe facilities associated with this application.

Minor revisions to the proposed labeling and labels willbe made when the clinical

division initiates labeling negotiations with the applicant.²The proposed labeling

is otherwise adequate to meet the regulatory requirements.

b.Is the overall recommendation in agreement with the individual

discipline recommendations? Yes

Recommendation by Subdiscipline:

Drug Substance -Adequate

Drug Product -Adequate

1https://darrts.fda.gov/darrts/ViewDocument?documentld=090140af806ecb99&showAsPdf=true

2 Refer to the Labeling Review for further details.

Page 2 of 3

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标签： #FDA #产品质量 #质量审评

摘要：

CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:217388Orig1s000PRODUCTQUALITYREVIEW(S)CenterforDrugEvaluationandResearchOfficeofPharmaceuticalQualityNDAExecutiveSummary1.Application/ProductInformationNDANumber217388ApplicantNamelonisInc.DrugProductNameTRADENAME(eplontersen)DosageFormInjectionPro...

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