{
 "decision": {
  "id": "kisunla-2024-traditional",
  "title": "Kisunla, traditional approval",
  "outcome": "approved",
  "pathway": "Traditional approval",
  "case": "BUILT",
  "action_date": "2024-07-02",
  "incomplete": false
 },
 "package": "donanemab_bla761248",
 "documents": [
  {
   "code": "ltr",
   "title": "Approval letter",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761248Orig1s000ltr.pdf",
   "pages": 11,
   "sha256": "f88317e7252808fbe9bb33e48ba777327ce29563fcf60f1d2981ccef1e01b2e3",
   "cited": true
  },
  {
   "code": "SumR",
   "title": "Summary review",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf",
   "pages": 113,
   "sha256": "bb9356f5158a4862677df56b0802535a47e17b4d89f2adb79decae5c4b43dfab",
   "cited": true
  },
  {
   "code": "MedR",
   "title": "Clinical review",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000MedR.pdf",
   "pages": 621,
   "sha256": "93bdf1fad077f19d7ac8c8a3207c7d3fef079cc5bc222723be4163d2c4bde194",
   "cited": false
  },
  {
   "code": "StatR",
   "title": "Statistical review",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000StatR.pdf",
   "pages": 111,
   "sha256": "024565fe8c129d3ef9c80343a8f5f240c0636217e8838c8eb9a1829eb7c82787",
   "cited": false
  },
  {
   "code": "761248s000lbl",
   "title": "Prescribing information (label)",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf",
   "pages": 17,
   "sha256": "54cd9855816af3052ed621d37ed476ce69474d3e811fc21a0202b9c2c1cb7fa2",
   "cited": false
  },
  {
   "code": "AdComBriefing",
   "title": "Advisory committee briefing document (FDA, June 10, 2024)",
   "url": "https://www.fda.gov/media/179166/download",
   "pages": 44,
   "sha256": "d97079fd5d94f5f12a5b1c9d90889493dc85b087ec3cacf8ddd549563ab54cd1",
   "cited": false
  },
  {
   "code": "AdComMinutes",
   "title": "Advisory committee minutes (June 10, 2024)",
   "url": "https://www.fda.gov/media/180111/download",
   "pages": 7,
   "sha256": "830588ba2dd19be26aa71777a585c72764b77ecc5b1263664c7475cd8f65b5cd",
   "cited": true
  },
  {
   "code": "AdComTranscript",
   "title": "Advisory committee transcript (June 10, 2024)",
   "url": "https://www.fda.gov/media/180365/download",
   "pages": 305,
   "sha256": "1b24b2480689333614139ead4f70b199dcfe0d6244c255139848a827090e3414",
   "cited": false
  }
 ],
 "missing_documents": [],
 "facts": {
  "action_date": {
   "doc": "ltr",
   "page": 11,
   "excerpt": "TERESA J BURACCHIO 07/02/2024",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761248Orig1s000ltr.pdf#page=11",
   "value": "2024-07-02"
  },
  "sponsor": {
   "doc": "ltr",
   "page": 1,
   "excerpt": "Eli Lilly and Company",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761248Orig1s000ltr.pdf#page=1",
   "value": "Eli Lilly and Company"
  },
  "basis": {
   "quote": "Together, the results of these two adequate and well-controlled studies, AACI and AACG, provide substantial evidence of effectiveness for donanemab for the treatment of Alzheimer’s disease.",
   "doc": "SumR",
   "page": 4,
   "sid": "SumR:p4:s15",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf#page=4",
   "label": "Studies AACI and AACG (clinical efficacy)"
  },
  "committee": {
   "doc": "AdComMinutes",
   "page": 5,
   "excerpt": "June 10, 2024 Peripheral and Central Nervous System Drugs Advisory Committee Meeting Page 5",
   "url": "https://www.fda.gov/media/180111/download#page=5",
   "name": "Peripheral and Central Nervous System Drugs Advisory Committee",
   "date": "2024-06-10",
   "votes": [
    {
     "doc": "AdComMinutes",
     "page": 5,
     "excerpt": "Do the available data show that donanemab is effective for the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia? • In determining your vote, if you believe there is efficacy across the entire population, or efficacy only in subset of patients (e.g., those with low/med and high Tau), please indicate that with a YES vote. • If your assessment is that efficacy has not been established in any subset of patients, then please indicate that with a NO vote. Explain the rationale for your vote. If you voted NO, please indicate in the discussion of your vote what additional data would be needed to support the effectiveness of donanemab for the treatment of Alzheimer’s disease. Vote Result: Yes: 11 No: 0 Abstain: 0",
     "url": "https://www.fda.gov/media/180111/download#page=5",
     "question": "2",
     "yes": 11,
     "no": 0,
     "uncertain": 0,
     "third_label": "abstain",
     "headline": true
    },
    {
     "doc": "AdComMinutes",
     "page": 6,
     "excerpt": "Do the benefits outweigh the risks of donanemab in the treatment of AD in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia? • Explain the rationale for your vote. • If you voted NO, provide recommendations for additional data or analyses that may support a conclusion that the benefits outweigh the risks. Vote Result: Yes: 11 No: 0 Abstain: 0",
     "url": "https://www.fda.gov/media/180111/download#page=6",
     "question": "5",
     "yes": 11,
     "no": 0,
     "uncertain": 0,
     "third_label": "abstain",
     "headline": false
    }
   ]
  },
  "confirmatory": {
   "quote": "Conduct a randomized, double-blind, controlled trial of donanemab in participants with early-stage Alzheimer’s disease.",
   "doc": "ltr",
   "page": 8,
   "sid": "ltr:p8:s6",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761248Orig1s000ltr.pdf#page=8",
   "label": "PMC 4605-3: randomized trial of maintenance dosing"
  }
 },
 "sponsor_ask": {
  "quote": "The Applicant is seeking traditional approval based primarily on results from Study AACI, a multicenter, randomized, double-blind, placebo-controlled, parallel group study in subjects with early symptomatic Alzheimer’s disease.",
  "doc": "SumR",
  "page": 3,
  "sid": "SumR:p3:s14",
  "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf#page=3"
 },
 "positions": [
  {
   "quote": "The effect on the ADAS-cog, iADL, and CDR-SB endpoints in Study AACI represent a clinically meaningful reduction of clinical decline.",
   "doc": "SumR",
   "page": 4,
   "sid": "SumR:p4:s9",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf#page=4",
   "id": "KIS-T2-1",
   "thread": "T2",
   "status": "Consistent",
   "compares_to": "LQT-T2-1",
   "status_review": "reviewed"
  },
  {
   "quote": "The incidence of ARIA in AACI was higher in ApoE ε4 homozygotes (55% on donanemab vs. 22% on placebo) than in heterozygotes (36% on donanemab vs 13% on placebo) and noncarriers (25% on donanemab vs 12% on placebo).",
   "doc": "SumR",
   "page": 6,
   "sid": "SumR:p6:s11",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf#page=6",
   "id": "KIS-T3-1",
   "thread": "T3",
   "status": "Consistent",
   "compares_to": "LQT-T3-1",
   "status_review": "reviewed"
  },
  {
   "quote": "The safety of donanemab was characterized in a safety database of adequate size.",
   "doc": "SumR",
   "page": 5,
   "sid": "SumR:p5:s5",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf#page=5",
   "id": "KIS-T4-1",
   "thread": "T4",
   "status": "Consistent",
   "compares_to": "DON-T4-1",
   "status_review": "reviewed"
  },
  {
   "quote": "Together, the results of these two adequate and well-controlled studies, AACI and AACG, provide substantial evidence of effectiveness for donanemab for the treatment of Alzheimer’s disease.",
   "doc": "SumR",
   "page": 4,
   "sid": "SumR:p4:s15",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000SumR.pdf#page=4",
   "id": "KIS-T4-2",
   "thread": "T4",
   "status": "Consistent",
   "compares_to": "LQT-T4-1",
   "status_review": "reviewed"
  }
 ],
 "edges": [
  {
   "from": "KIS-T2-1",
   "from_decision": "kisunla-2024-traditional",
   "to": "LQT-T2-1",
   "to_decision": "leqembi-2023-traditional",
   "status": "Consistent",
   "thread": "T2"
  },
  {
   "from": "KIS-T3-1",
   "from_decision": "kisunla-2024-traditional",
   "to": "LQT-T3-1",
   "to_decision": "leqembi-2023-traditional",
   "status": "Consistent",
   "thread": "T3"
  },
  {
   "from": "KIS-T4-1",
   "from_decision": "kisunla-2024-traditional",
   "to": "DON-T4-1",
   "to_decision": "donanemab-2023-crl",
   "status": "Consistent",
   "thread": "T4"
  },
  {
   "from": "KIS-T4-2",
   "from_decision": "kisunla-2024-traditional",
   "to": "LQT-T4-1",
   "to_decision": "leqembi-2023-traditional",
   "status": "Consistent",
   "thread": "T4"
  },
  {
   "from": "IQM-T3-2",
   "from_decision": "leqembi-iqlik-maintenance",
   "to": "KIS-T3-1",
   "to_decision": "kisunla-2024-traditional",
   "status": "Consistent",
   "thread": "T3"
  }
 ]
}