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
Rx
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
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
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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CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:217388Orig1s000PRODUCTQUALITYREVIEW(S)CenterforDrugEvaluationandResearchOfficeofPharmaceuticalQualityNDAExecutiveSummary1.Application/ProductInformationNDANumber217388ApplicantNamelonisInc.DrugProductNameTRADENAME(eplontersen)DosageFormInjectionPro...
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作者：冒牌货
分类：专业资料
价格：100质量币
属性：22 页
大小：446.77KB
格式：PDF
时间：2026-01-13
