clinical approval outlook derived

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      "agency": "FDA | EMA | both (default: both)",
      "horizon": "12m | 18m | 24m (default: 18m)",
      "condition": "Disease area — e.g. \"Alzheimer Disease\" | \"Multiple Myeloma\" | \"NASH\" | \"Heart Failure\" | \"Obesity\""
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        "agencies": [
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          "EMA"
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        "condition": "Alzheimer Disease"
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      "market_context": "Alzheimer's is the highest-value CNS approval category. Any successful amyloid or tau therapy represents $5-15B peak sales potential.",
      "pdufa_calendar": [
        {
          "drug": "Donanemab",
          "sponsor": "Eli Lilly",
          "indication": "Early symptomatic AD",
          "pdufa_date": "2025-Q2",
          "priority_review": true
        }
      ],
      "approval_candidates": [
        {
          "drug": "Lecanemab (Leqembi)",
          "nctId": "NCT03887455",
          "sponsor": "Eisai / Biogen",
          "key_risk": "ARIA (amyloid-related imaging abnormalities) safety profile limiting real-world use",
          "mechanism": "Anti-amyloid monoclonal antibody (protofibrils)",
          "ema_status": "CHMP assessment ongoing 2025",
          "fda_status": "Full approval received 2023; expanded label applications pending",
          "trial_result": "Positive — 27% slowing of clinical decline vs placebo (p<0.001)",
          "approval_probability": 85
        }
      ],
      "approval_rate_context": {
        "rare_disease_premium": "Breakthrough therapy designation adds ~15% probability uplift",
        "us_approval_rate_phase3_pct": 58,
        "disease_area_historical_phase3_success_pct": 55
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