{
 "decision": {
  "id": "donanemab-2023-crl",
  "title": "Donanemab, complete response letter",
  "outcome": "refused",
  "pathway": "Complete response",
  "case": "BUILT",
  "action_date": "2023-01-18",
  "incomplete": false
 },
 "package": "donanemab_bla761248",
 "documents": [
  {
   "code": "OtherActionLtrs",
   "title": "Complete response letter",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf",
   "pages": 8,
   "sha256": "e9314cbe6375abc60d9611d5dc7039c8368ee66261afdd0945f2d7df2a5466ef",
   "cited": true
  }
 ],
 "missing_documents": [],
 "facts": {
  "action_date": {
   "doc": "OtherActionLtrs",
   "page": 8,
   "excerpt": "WILLIAM H Dunn 01/18/2023",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf#page=8",
   "value": "2023-01-18"
  },
  "sponsor": {
   "quote": "Eli Lilly and Company",
   "doc": "OtherActionLtrs",
   "page": 2,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf#page=2",
   "transcription": "Scanned page: FDA's published text of this letter, each line confirmed by an independent OCR of the page.",
   "value": "Eli Lilly and Company"
  },
  "basis": {
   "quote": "The safety database is insufficient to adequately characterize the long-term safety of Kisunla in the treatment of Alzheimer’s disease.",
   "doc": "OtherActionLtrs",
   "page": 2,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf#page=2",
   "transcription": "Scanned page: FDA's published text of this letter, each line confirmed by an independent OCR of the page.",
   "label": "Safety database insufficient for long-term safety"
  },
  "committee": {
   "doc": "OtherActionLtrs",
   "page": null,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf",
   "pattern": "(?i)advisory\\s+committee",
   "mentioned": false
  }
 },
 "sponsor_ask": {
  "quote": "We acknowledge that you have tried to meet the exposure requirements through a “treatment protocol” approach based on the dosage regimen of Kisunla specified in the protocol, in which the Kisunla dose was either reduced or stopped when amyloid beta plaque measurements declined to a pre-specified threshold on PET imaging.",
  "doc": "OtherActionLtrs",
  "page": 2,
  "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf#page=2",
  "transcription": "Scanned page: FDA's published text of this letter, each line confirmed by an independent OCR of the page."
 },
 "positions": [
  {
   "quote": "The safety database is insufficient to adequately characterize the long-term safety of Kisunla in the treatment of Alzheimer’s disease.",
   "doc": "OtherActionLtrs",
   "page": 2,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf#page=2",
   "transcription": "Scanned page: FDA's published text of this letter, each line confirmed by an independent OCR of the page.",
   "id": "DON-T4-1",
   "thread": "T4",
   "status": "Consistent",
   "compares_to": "ADU-T4-3",
   "status_review": "reviewed"
  },
  {
   "quote": "Your BLA submission contains data for only 49 patients who were exposed to Kisunla at the highest proposed dosage regimen (700 mg for 3 doses followed by 1400 mg thereafter) for 12 months.",
   "doc": "OtherActionLtrs",
   "page": 2,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761248Orig1s000OtherActionLtrs.pdf#page=2",
   "transcription": "Scanned page: FDA's published text of this letter, each line confirmed by an independent OCR of the page.",
   "id": "DON-T4-2",
   "thread": "T4",
   "status": "Consistent",
   "compares_to": "ADU-T4-3",
   "status_review": "reviewed"
  }
 ],
 "edges": [
  {
   "from": "DON-T4-1",
   "from_decision": "donanemab-2023-crl",
   "to": "ADU-T4-3",
   "to_decision": "aduhelm-2021-aa",
   "status": "Consistent",
   "thread": "T4"
  },
  {
   "from": "DON-T4-2",
   "from_decision": "donanemab-2023-crl",
   "to": "ADU-T4-3",
   "to_decision": "aduhelm-2021-aa",
   "status": "Consistent",
   "thread": "T4"
  },
  {
   "from": "KIS-T4-1",
   "from_decision": "kisunla-2024-traditional",
   "to": "DON-T4-1",
   "to_decision": "donanemab-2023-crl",
   "status": "Consistent",
   "thread": "T4"
  }
 ]
}