{
 "decision": {
  "id": "leqembi-iqlik-maintenance",
  "title": "Leqembi Iqlik, subcutaneous maintenance",
  "outcome": "approved",
  "pathway": "Subcutaneous maintenance dosing",
  "case": "BUILT",
  "action_date": "2025-08-29",
  "incomplete": false
 },
 "package": "lecanemab_iqlik_bla761375",
 "documents": [
  {
   "code": "ltr",
   "title": "Approval letter",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761375Orig1s000ltr.pdf",
   "pages": 48,
   "sha256": "30714a36c87d60abb2ac6db482d78ef3a772a77d4841fe5e18e9002e395f6c08",
   "cited": true
  },
  {
   "code": "761375s000lbl",
   "title": "Prescribing information (label)",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf",
   "pages": 37,
   "sha256": "32ab5f7ebc20ffb0ad544ab9bbe938c874333e6d10a6ae53ec312800152cd356",
   "cited": true
  }
 ],
 "missing_documents": [],
 "facts": {
  "action_date": {
   "doc": "ltr",
   "page": 48,
   "excerpt": "TERESA J BURACCHIO 08/29/2025",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761375Orig1s000ltr.pdf#page=48",
   "value": "2025-08-29"
  },
  "basis": {
   "quote": "After 18 months, the starting dosage may be continued or a transition to maintenance dosage regimen may be considered, which can be administered by either intravenous infusion or subcutaneous injection (see Table 1).",
   "doc": "761375s000lbl",
   "page": 3,
   "sid": "761375s000lbl:p3:s28",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf#page=3",
   "label": "Subcutaneous maintenance dosing after 18 months"
  },
  "committee": {
   "quote": "Your application for Leqembi IQLIK was not referred to an FDA advisory committee because this biologic is not the first in its class.",
   "doc": "ltr",
   "page": 2,
   "sid": "ltr:p2:s20",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761375Orig1s000ltr.pdf#page=2",
   "referred": false
  },
  "confirmatory": {
   "quote": "For potential fulfillment of PMR 4871-1, patients treated with Leqembi IQLIK can be enrolled in studies intended to fulfill PMR 4497-1 for Leqembi.",
   "doc": "ltr",
   "page": 4,
   "sid": "ltr:p4:s21",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761375Orig1s000ltr.pdf#page=4",
   "label": "PMR 4871-1: registry study, via Leqembi's PMR 4497-1"
  }
 },
 "sponsor_ask": null,
 "positions": [
  {
   "quote": "Finally, we have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a known serious risk of amyloid related imaging abnormalities in patients who are homozygous for ApoE e4.",
   "doc": "ltr",
   "page": 5,
   "sid": "ltr:p5:s21",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761375Orig1s000ltr.pdf#page=5",
   "id": "IQM-T3-1",
   "thread": "T3",
   "status": "Consistent",
   "compares_to": "LQT-T3-1",
   "status_review": "reviewed"
  },
  {
   "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": "761375s000lbl",
   "page": 3,
   "sid": "761375s000lbl:p3:s10",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf#page=3",
   "id": "IQM-T3-2",
   "thread": "T3",
   "status": "Consistent",
   "compares_to": "KIS-T3-1",
   "status_review": "reviewed"
  }
 ],
 "edges": [
  {
   "from": "IQM-T3-1",
   "from_decision": "leqembi-iqlik-maintenance",
   "to": "LQT-T3-1",
   "to_decision": "leqembi-2023-traditional",
   "status": "Consistent",
   "thread": "T3"
  },
  {
   "from": "IQM-T3-2",
   "from_decision": "leqembi-iqlik-maintenance",
   "to": "KIS-T3-1",
   "to_decision": "kisunla-2024-traditional",
   "status": "Consistent",
   "thread": "T3"
  },
  {
   "from": "IQI-T3-1",
   "from_decision": "leqembi-iqlik-initiation",
   "to": "IQM-T3-2",
   "to_decision": "leqembi-iqlik-maintenance",
   "status": "Consistent",
   "thread": "T3"
  }
 ]
}