{
 "decision": {
  "id": "leqembi-2023-traditional",
  "title": "Leqembi, traditional approval",
  "outcome": "approved",
  "pathway": "Traditional approval",
  "case": "BUILT",
  "action_date": "2023-07-06",
  "incomplete": false
 },
 "package": "lecanemab_bla761269_s001",
 "documents": [
  {
   "code": "ltr_o1s001",
   "title": "Supplement approval letter",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf",
   "pages": 17,
   "sha256": "bd7bec6c00cddc20a721ae0e2cfddcfab903b234b3d89736013a39c309c441ce",
   "cited": true
  },
  {
   "code": "761269Orig1s001",
   "title": "Approval package (reviews)",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf",
   "pages": 495,
   "sha256": "e74fb0d9c8a01c058b03d654cd8b9d6a4f2a5d07b8e21149a6e46d5c4609b747",
   "cited": true
  },
  {
   "code": "lbl_o1s001",
   "title": "Prescribing information (label)",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf",
   "pages": 23,
   "sha256": "d1908d5e122ba1289c70e2fbf9f4185b32d6a6447c92672101a59b4fd8f1e53b",
   "cited": true
  },
  {
   "code": "AdComBriefing",
   "title": "Advisory committee briefing document (FDA, June 9, 2023)",
   "url": "https://www.fda.gov/media/169263/download",
   "pages": 35,
   "sha256": "d4fba843f8e6365ff7cea5c8dc9eafda67f50e068cd1027e32cef1e59273a5b9",
   "cited": false
  },
  {
   "code": "AdComMinutes",
   "title": "Advisory committee minutes (June 9, 2023)",
   "url": "https://www.fda.gov/media/170179/download",
   "pages": 6,
   "sha256": "b97e0025d702448c64193954ee67a1393dbaac86a69837d768c4590bc51eb3ed",
   "cited": true
  },
  {
   "code": "AdComTranscript",
   "title": "Advisory committee transcript (June 9, 2023)",
   "url": "https://www.fda.gov/media/171724/download",
   "pages": 270,
   "sha256": "172abd07a29ad513191f16aa91558d21b43ac0c3e366a9633b405867c4cf6977",
   "cited": false
  }
 ],
 "missing_documents": [],
 "facts": {
  "action_date": {
   "doc": "ltr_o1s001",
   "page": 17,
   "excerpt": "TERESA J BURACCHIO 07/06/2023",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf#page=17",
   "value": "2023-07-06"
  },
  "sponsor": {
   "doc": "ltr_o1s001",
   "page": 8,
   "excerpt": "Eisai Inc.",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf#page=8",
   "value": "Eisai Inc."
  },
  "basis": {
   "quote": "LEQEMBI treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months (-0.45 [-27%], p<0.0001).",
   "doc": "761269Orig1s001",
   "page": 38,
   "sid": "761269Orig1s001:p38:s14",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf#page=38",
   "label": "Study 301 (CLARITY AD): CDR-SB at 18 months"
  },
  "committee": {
   "doc": "AdComMinutes",
   "page": 5,
   "excerpt": "June 9, 2023 Peripheral and Central Nervous System Drugs Advisory Committee Meeting Page 5",
   "url": "https://www.fda.gov/media/170179/download#page=5",
   "name": "Peripheral and Central Nervous System Drugs Advisory Committee",
   "date": "2023-06-09",
   "votes": [
    {
     "doc": "AdComMinutes",
     "page": 5,
     "excerpt": "Do the results of Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? Vote Result: Yes: 6 No: 0 Abstain: 0",
     "url": "https://www.fda.gov/media/170179/download#page=5",
     "question": "2",
     "yes": 6,
     "no": 0,
     "uncertain": 0,
     "third_label": "abstain",
     "headline": true
    }
   ]
  },
  "confirmatory": {
   "quote": "We have reviewed your submission and conclude that the above requirement was fulfilled.",
   "doc": "ltr_o1s001",
   "page": 10,
   "sid": "ltr_o1s001:p10:s5",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf#page=10",
   "label": "PMR 4384-1 fulfilled (Study 301)"
  }
 },
 "sponsor_ask": {
  "quote": "In this BLA supplement, the Applicant is seeking traditional approval of lecanemab.",
  "doc": "761269Orig1s001",
  "page": 63,
  "sid": "761269Orig1s001:p63:s8",
  "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf#page=63"
 },
 "positions": [
  {
   "quote": "These approvals were based on a demonstration of reduction of amyloid beta on PET imaging, a surrogate endpoint that was determined to be reasonably likely to predict clinical benefit.",
   "doc": "761269Orig1s001",
   "page": 50,
   "sid": "761269Orig1s001:p50:s11",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf#page=50",
   "id": "LQT-T1-1",
   "thread": "T1",
   "status": "Consistent",
   "compares_to": "LEQ-T1-1",
   "status_review": "reviewed"
  },
  {
   "quote": "The effect on the primary endpoint represents a clinically meaningful reduction of clinical decline.",
   "doc": "761269Orig1s001",
   "page": 51,
   "sid": "761269Orig1s001:p51:s20",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf#page=51",
   "id": "LQT-T2-1",
   "thread": "T2",
   "status": "Consistent",
   "compares_to": "LEQ-T2-1",
   "status_review": "reviewed"
  },
  {
   "quote": "Since Leqembi was approved on January 6, 2023, we have become aware of clinical trial data showing an increased risk of symptomatic, serious, and severe radiographic amyloid related imaging abnormalities (ARIA) in ApoE ε4 homozygotes who are treated with Leqembi compared to heterozygotes and noncarriers.",
   "doc": "ltr_o1s001",
   "page": 10,
   "sid": "ltr_o1s001:p10:s8",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf#page=10",
   "id": "LQT-T3-1",
   "thread": "T3",
   "status": "Consistent",
   "compares_to": "LEQ-T3-1",
   "status_review": "reviewed"
  },
  {
   "quote": "Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.",
   "doc": "lbl_o1s001",
   "page": 2,
   "sid": "lbl_o1s001:p2:s10",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf#page=2",
   "id": "LQT-T3-2",
   "thread": "T3",
   "status": "Departs",
   "compares_to": "LEQ-T3-3",
   "status_review": "reviewed"
  },
  {
   "quote": "The collective evidence from Study 201 and 301 continue to demonstrate substantial evidence of effectiveness for lecanemab for the treatment of Alzheimer’s disease, and support the traditional approval of lecanemab in this population.",
   "doc": "761269Orig1s001",
   "page": 51,
   "sid": "761269Orig1s001:p51:s19",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf#page=51",
   "id": "LQT-T4-1",
   "thread": "T4",
   "status": "Consistent",
   "compares_to": "LEQ-T4-1",
   "status_review": "reviewed"
  },
  {
   "quote": "We have reviewed your submission and conclude that the above requirement was fulfilled.",
   "doc": "ltr_o1s001",
   "page": 10,
   "sid": "ltr_o1s001:p10:s5",
   "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf#page=10",
   "id": "LQT-T5-1",
   "thread": "T5",
   "status": "Consistent",
   "compares_to": "LEQ-T5-1",
   "status_review": "reviewed"
  }
 ],
 "edges": [
  {
   "from": "LQT-T1-1",
   "from_decision": "leqembi-2023-traditional",
   "to": "LEQ-T1-1",
   "to_decision": "leqembi-2023-aa",
   "status": "Consistent",
   "thread": "T1"
  },
  {
   "from": "LQT-T2-1",
   "from_decision": "leqembi-2023-traditional",
   "to": "LEQ-T2-1",
   "to_decision": "leqembi-2023-aa",
   "status": "Consistent",
   "thread": "T2"
  },
  {
   "from": "LQT-T3-1",
   "from_decision": "leqembi-2023-traditional",
   "to": "LEQ-T3-1",
   "to_decision": "leqembi-2023-aa",
   "status": "Consistent",
   "thread": "T3"
  },
  {
   "from": "LQT-T3-2",
   "from_decision": "leqembi-2023-traditional",
   "to": "LEQ-T3-3",
   "to_decision": "leqembi-2023-aa",
   "status": "Departs",
   "thread": "T3"
  },
  {
   "from": "LQT-T4-1",
   "from_decision": "leqembi-2023-traditional",
   "to": "LEQ-T4-1",
   "to_decision": "leqembi-2023-aa",
   "status": "Consistent",
   "thread": "T4"
  },
  {
   "from": "LQT-T5-1",
   "from_decision": "leqembi-2023-traditional",
   "to": "LEQ-T5-1",
   "to_decision": "leqembi-2023-aa",
   "status": "Consistent",
   "thread": "T5"
  },
  {
   "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-T4-2",
   "from_decision": "kisunla-2024-traditional",
   "to": "LQT-T4-1",
   "to_decision": "leqembi-2023-traditional",
   "status": "Consistent",
   "thread": "T4"
  },
  {
   "from": "IQM-T3-1",
   "from_decision": "leqembi-iqlik-maintenance",
   "to": "LQT-T3-1",
   "to_decision": "leqembi-2023-traditional",
   "status": "Consistent",
   "thread": "T3"
  }
 ]
}