{
 "decision": {
  "id": "leqembi-iqlik-initiation",
  "title": "Leqembi Iqlik, subcutaneous initiation",
  "outcome": "approved",
  "pathway": "Subcutaneous initiation dosing",
  "case": "BUILT",
  "action_date": "2026-07-13",
  "incomplete": false
 },
 "package": "lecanemab_iqlik_bla761375_s001",
 "documents": [
  {
   "code": "ltr_o1s001",
   "title": "Supplement approval letter",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf",
   "pages": 5,
   "sha256": "b9a1f5b37c133cf83927741719e2107bf381974f57ee440e7d0b84480f5609df",
   "cited": true
  },
  {
   "code": "761375s001lbl",
   "title": "Prescribing information (label)",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761375s001lbl.pdf",
   "pages": 51,
   "sha256": "13c60441934ef4a5f827b8b5e40727d81bd282f90831ec4ef3425243d5bbea9c",
   "cited": true
  }
 ],
 "missing_documents": [],
 "facts": {
  "action_date": {
   "doc": "ltr_o1s001",
   "page": 5,
   "excerpt": "EMILY R FREILICH 07/13/2026",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf#page=5",
   "value": "2026-07-13"
  },
  "sponsor": {
   "doc": "ltr_o1s001",
   "page": 1,
   "excerpt": "Eisai Inc.",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf#page=1",
   "value": "Eisai Inc."
  },
  "basis": {
   "quote": "This Prior Approval sBLA provides for a new 250 mg/1.25 mL (200 mg/mL) single-dose prefilled Leqembi Iqlik autoinjector, which provides for the new subcutaneous starting dosage regimen of Leqembi IQLIK at a dose of 500 mg once every week, for the treatment of Alzheimer’s disease.",
   "doc": "ltr_o1s001",
   "page": 1,
   "sid": "ltr_o1s001:p1:s12",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf#page=1",
   "label": "Subcutaneous starting dose, 500 mg weekly"
  },
  "committee": {
   "doc": "ltr_o1s001",
   "page": null,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf",
   "pattern": "(?i)advisory\\s+committee",
   "mentioned": false
  },
  "confirmatory": {
   "doc": "ltr_o1s001",
   "page": null,
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761375Orig1s001ltr.pdf",
   "pattern": "(?i)postmarketing\\s+requirement|\\bPMR\\b|confirmatory",
   "mentioned": false,
   "label": "No postmarketing requirement in the letter"
  }
 },
 "sponsor_ask": null,
 "positions": [
  {
   "quote": "Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers.",
   "doc": "761375s001lbl",
   "page": 3,
   "sid": "761375s001lbl:p3:s10",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761375s001lbl.pdf#page=3",
   "id": "IQI-T3-1",
   "thread": "T3",
   "status": "Consistent",
   "compares_to": "IQM-T3-2",
   "status_review": "reviewed"
  }
 ],
 "edges": [
  {
   "from": "IQI-T3-1",
   "from_decision": "leqembi-iqlik-initiation",
   "to": "IQM-T3-2",
   "to_decision": "leqembi-iqlik-maintenance",
   "status": "Consistent",
   "thread": "T3"
  }
 ]
}