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` BLA 761063/S-06
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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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`Consultant, 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 December 1, 2021, submitted under section 351(a) of the Public Health
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`Service Act for Emgality (galcanezumab-gnlm) injection.
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`This Changes Being Effected sBLA provides for inclusion of the pregnancy exposure
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`registry information in the Emgality labeling.
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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
` FDA.gov,1 that is identical to the enclosed labeling (text for the Prescribing Information,
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` Patient Package Insert, and Instructions for Use) and include the labeling changes
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` proposed in any pending “Changes 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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`The SPL will be accessible via publicly available labeling repositories.
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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: 4988199
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` BLA 761063/S-06
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`Page 2
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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
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`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
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`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
`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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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format—Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
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`As required under 21 CFR 601.12(f)(4), you must submit final promotional materials,
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`and the Prescribing Information, at the time of initial dissemination or publication,
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`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and Instructions for completing the form can be found at FDA.gov.5
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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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` 3 For the most recent version of a guidance, check the FDA guidance web page
` athttps://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`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: 4988199
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`BLA 761063/S-06
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`Page 3
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`If you have any questions, call Daniel Ngembus, Regulatory Project Manager, by email at
`daniel.ngembus@fda.hhs.gov or by phone at (301) 837-7345.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Alice T.D. Hughes, MD
`Deputy Director for Safety
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`Division of Neurology 2
`Office of Neuroscience
`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
`o Patient Package Insert
`Instructions for Use
`o
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` U.S. Food and Drug Administration
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` Silver Spring, MD 20993
` www.fda.gov
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`Reference ID: 4988199
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`Signature Page 1 of 1
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`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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`ALICE HUGHES
`05/24/2022 02:45:17 PM
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`Reference ID: 4988199
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`(
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