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`ADMIN I STRATION
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` BLA 125521/S-024
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` SUPPLEMENT APPROVAL
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`Eli Lilly and Company
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`Attention: Mitchell R. Cunningham, PharmD
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`Associate Director, Global Regulatory Affairs – North America
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`Lilly Corporate Center
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`Indianapolis, IN 46285
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`Dear Dr. Cunningham:
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`Please refer to your supplemental biologics license application (sBLA), dated and
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`received January 5, 2022, and your amendments, submitted under section 351(a) of the
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`Public Health Service Act for Taltz (ixekizumab) injection.
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`This “Changes Being Effected” supplemental biologics application provides for updates
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`to Sections 8.1, 8.2, and 17 of the prescribing information and to the Medication Guide
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`with Pregnancy Exposure Registry information.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit, via
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`the FDA automated drug registration and listing system (eLIST), the content of labeling
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`[21 CFR 601.14(b)] in structured product labeling (SPL) format, as described at
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`FDA.gov,1 that is identical to the enclosed labeling Prescribing Information and
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`Medication Guide and include the labeling changes proposed in any pending “Changes
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`Being Effected” (CBE) supplements.
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`Information on submitting SPL files using eLIST may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 5019857
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` BLA 125521/S-024
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` Page 2
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`The SPL will be accessible via publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that include labeling
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` changes for this BLA, including pending “Changes Being Effected” (CBE) supplements,
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` for which FDA has not yet issued an action letter, with the content of labeling [21 CFR
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` 601.12(f)] in Microsoft Word format that includes the changes approved in this
` supplemental application, as well as annual reportable changes. To facilitate review of
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` your submission(s), provide a highlighted or marked-up copy that shows all changes, as
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`well as a clean Microsoft Word version. The marked-up copy should provide appropriate
`annotations, including supplement number(s) and annual report date(s).
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved BLA
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`(in 21 CFR 600.80 and in 21 CFR 600.81).
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`Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
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`comply with postmarketing safety reporting requirements for an approved combination
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`product (21 CFR 4, Subpart B). Additional information on combination product
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`postmarketing safety reporting is available at FDA.gov.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5019857
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`BLA 125521/S-024
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`Page 3
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`If you have any questions, call H. F. Van Horn III, PharmD, MBA, Regulatory Project
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`Manager, at (301) 837-7389.
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`Sincerely,
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`{See appended electronic signature page}
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`Tatiana Oussova, MD, MPH
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`Deputy Director for Safety
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`Division of Dermatology and Dentistry
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`Office of Immunology and Inflammation
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`Office of New Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5019857
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
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`TATIANA OUSSOVA
`07/27/2022 01:54:23 PM
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`■
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`Reference ID: 5019857
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`(
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