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  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2015-01-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "letter_date": "04/22/2026",
      "approver_title": null,
      "file_name": "CRL_BLA761459_20260422.pdf",
      "letter_year": "2026",
      "approval_status": "Unapproved",
      "approver_name": "Center for Drug Evaluation and Research",
      "approver_center": [],
      "company_rep": "Felipe Martins",
      "company_address": "2525 Dupont Drive\nIrvine, CA 92612",
      "company_name": "AbbVie Inc.",
      "text": "nN U.S. FOOD & DRUG\n\nADMINISTRATION\n\nBLA 761459\nCOMPLETE RESPONSE\n\nAbbVie Inc.\n\nAttention: Felipe Martins\n\nAssociate Director, Regulatory Affairs\n2525 Dupont Drive\n\nIrvine, CA 92612\n\nDear Felipe Martins:\n\nPlease refer to your biologics license application (BLA) dated and received\n\nApril 22, 2025, and your amendments, submitted under\n\nan for AGN-151586 for injection.\n\nWe also acknowledge receipt of your amendment dated April 17, 2026, which was not\n\nreviewed for this action. You may incorporate applicable sections of the amendment by\nspecific reference as part of your response to the deficiencies cited in this letter.\n\nWe have completed our review of this application, as amended, and have determined\nthat we cannot approve this application in its present form. We have described our\nreasons for this action below and, where possible, our recommendations to address\nthese issues.\n\nFACILITY INSPECTIONS\n\n1) Following pre-license inspection 0\n| listed in this application, conveyed deficiencies to the\n\nrepresentative of the facility. The facility should provide satisfactory responses to\nthese deficiencies to the FDA office indicated on FDA Form 483 prior to your\ncomplete response to your application. Your complete response should include\nthe date(s) of the facility's response to FDA Form 483. The assessment of\napplication approvability and the resolution of inspection deficiencies would be\nevaluated upon receipt of the complete response and may include re-inspection\nof the facility. Please work with the facility in resolving the related deficiencies.\n\nPRODUCT QUALITY\n\nReference ID: 5785294\n\nBLA 761459\nPage 2\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5785294\n\nBLA 761459\nPage 3\n\nPRESCRIBING INFORMATION\n\n4) We reserve comment on the proposed labeling until the application is otherwise\nadequate. We encourage you to review the labeling review resources on the\nPrescription Drug Labeling Resources’ and Pregnancy and Lactation Labeling\nFinal Rule? websites, including regulations and related guidance documents and\nthe Selected Requirements for Prescribing Information (SRPI) - a checklist of\nimportant format items from labeling regulations and guidances.\n\nIf you revise labeling, use the SRPI checklist to ensure that the Prescribing\nInformation conforms with format items in regulations and guidances. Your\nresponse must include updated content of labeling [21 CFR 601.14(b)] in\nstructured product labeling (SPL) format as described at FDA.gov.°\n\nCARTON AND CONTAINER LABELING\n\n5) We reserve comment on the proposed labeling until the application is otherwise\nadequate.\n\nMEDICATION GUIDE\n\n6) Add the following bolded statement or appropriate alternative to the carton and\ncontainer labeling per 21 CFR 208.24(d): \"ATTENTION PHARMACIST: Each\npatient is required to receive the enclosed Medication Guide.\"\n\n1\n2\n\n3\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5785294\n\nBLA 761459\nPage 4\n\nPROPRIETARY NAME\n\nPlease refer to our correspondence dated July 2, 2025, which addresses the proposed\nproprietary name, {@™). This name was found conditionally acceptable pending\napproval of the application in the current review cycle. Please resubmit the proposed\nproprietary name when you respond to all of the application deficiencies that have been\nidentified in this letter.\n\nSAFETY UPDATE\n\nWhen you respond to the above deficiencies, include a safety update as described at\n21 CFR 314.50(d)(5)(vi)(b). The safety update should include data from all nonclinical\nand clinical studies/trials of the product under consideration regardless of indication,\ndosage form, or dose level.\n\n(1) Describe in detail any significant changes or findings in the safety profile.\n\n(2) When assembling the sections describing discontinuations due to adverse\nevents, serious adverse events, and common adverse events, incorporate new\nsafety data as follows:\n\ne Present new safety data from the studies/clinical trials for the proposed\nindication using the same format as in the original submission.\n\ne Present tabulations of the new safety data combined with the original\napplication data.\n\ne Include tables that compare frequencies of adverse events in the original\napplication with the retabulated frequencies described in the bullet above.\n\ne For indications other than the proposed indication, provide separate tables for\nthe frequencies of adverse events occurring in Clinical trials.\n\n(3) Present a retabulation of the reasons for premature trial discontinuation by\nincorporating the drop-outs from the newly completed trials. Describe any new\ntrends or patterns identified.\n\n(4) Provide case report forms and narrative summaries for each subject who died\nduring a Clinical trial or who did not complete a trial because of an adverse event.\nIn addition, provide narrative summaries for serious adverse events.\n\n(5) Describe any information that suggests a substantial change in the incidence of\ncommon, but less serious, adverse events between the new data and the original\napplication data.\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5785294\n\nBLA 761459\nPage 5\n\n(6) Provide updated exposure information for the clinical studies/trials (e.g., number\nof subjects, person time).\n\n(7) Provide a summary of worldwide experience on the safety of this product. Include\nan updated estimate of use for product marketed in other countries.\n\n(8) Provide English translations of current approved foreign labeling not previously\nsubmitted.\n\nADDITIONAL COMMENTS:\n\nWe have the following comments that are not approvability issues:\n\nOTHER\n\nWithin one year after the date of this letter, you are required to resubmit or take other\nactions available under 21 CFR 601.3(b)). If you do not take one of these actions, we\nmay consider your lack of response a request to withdraw the application under\n\n21 CFR 601.3(c). You may also request an extension of time in which to resubmit the\napplication.\n\nA resubmission must fully address all the deficiencies listed in this letter and should be\nclearly marked with \"RESUBMISSION\" in large font, bolded type at the beginning of the\ncover letter of the submission. The cover letter should clearly state that you consider\nthis resubmission a complete response to the deficiencies outlined in this letter. A partial\nresponse to this letter will not be processed as a resubmission and will not start a new\nreview cycle.\n\nYou may request a meeting or teleconference with us to discuss what steps you need to\ntake before the application may be approved. If you wish to have such a meeting,\nsubmit your meeting request as described in the draft guidance for industry Formal\nMeetings Between the FDA and Sponsors or Applicants of PDUFA Products.\n\nThe product may not be legally marketed until you have been notified in writing that this\napplication is approved.\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5785294\n\nBLA 761459\n\nPage 6\nIf you have any questions, contact\n\nSincerely,\n\n{See appended electronic signature page}\n\nCenter for Drug Evaluation and Research\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5785294\n\nSignature Page 1 of 1\n\nThis is a representation of an electronic record that was signed\nelectronically. Following this are manifestations of any and all\nelectronic signatures for this electronic record.\n\n(b) (4)\n\n04/22/2026 01:23:25 PM\n\nReference ID: 5785294\n",
      "application_number": [
        "BLA 761459"
      ],
      "letter_type": "COMPLETE RESPONSE"
    }
  ]
}