From 7cae81e814ed1edc3cee93e9691796d9eb07f0cb Mon Sep 17 00:00:00 2001 From: Teleo Agents Date: Tue, 5 May 2026 04:18:27 +0000 Subject: [PATCH] vida: extract claims from 2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026 - Source: inbox/queue/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md - Domain: health - Claims: 0, Entities: 1 - Enrichments: 3 - Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5) Pentagon-Agent: Vida --- ...lass-effect-obesity-population-specific.md | 9 +++- ...rder-screening-recommended-not-required.md | 7 +++ entities/health/wegovy-oral.md | 49 +++++++++++++++++++ ...fda-oral-wegovy-approval-oasis4-jan2026.md | 5 +- 4 files changed, 68 insertions(+), 2 deletions(-) create mode 100644 entities/health/wegovy-oral.md rename inbox/{queue => archive/health}/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md (97%) diff --git a/domains/health/glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific.md b/domains/health/glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific.md index 376061f44..fe41b430f 100644 --- a/domains/health/glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific.md +++ b/domains/health/glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific.md @@ -11,7 +11,7 @@ sourced_from: health/2025-xx-vigibase-glp1-psychiatric-adverse-events-eating-dis scope: causal sourcer: Clinical Nutrition / VigiBase WHO supports: ["glp1-discontinuation-predicted-by-psychiatric-comorbidity-creating-access-adherence-trap", "glp1-pre-treatment-eating-disorder-screening-recommended-not-required"] -related: ["glp1-eating-disorder-risk-subtype-specific-protective-bed-harmful-restrictive", "glp1-pre-treatment-eating-disorder-screening-recommended-not-required", "glp1-psychiatric-effects-directionally-opposite-metabolic-versus-psychiatric-populations", "glp1-receptor-agonists-demonstrate-superior-efficacy-for-alcohol-use-disorder-in-comorbid-obesity-population", "semaglutide-reduces-depression-worsening-44-percent-in-diagnosed-patients-through-glp1r-psychiatric-mechanism", "glp1-anorexia-nervosa-evidence-absent-despite-pharmacovigilance-signal"] +related: ["glp1-eating-disorder-risk-subtype-specific-protective-bed-harmful-restrictive", "glp1-pre-treatment-eating-disorder-screening-recommended-not-required", "glp1-psychiatric-effects-directionally-opposite-metabolic-versus-psychiatric-populations", "glp1-receptor-agonists-demonstrate-superior-efficacy-for-alcohol-use-disorder-in-comorbid-obesity-population", "semaglutide-reduces-depression-worsening-44-percent-in-diagnosed-patients-through-glp1r-psychiatric-mechanism", "glp1-anorexia-nervosa-evidence-absent-despite-pharmacovigilance-signal", "glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific", "who-glp1-guideline-omits-eating-disorder-screening-despite-pharmacovigilance-signal"] --- # GLP-1 eating disorder pharmacovigilance signal (aROR 4.17-6.80) is a class effect that emerged specifically in the obesity treatment population after June 2021, not in the prior metabolic population @@ -38,3 +38,10 @@ Methodological discrepancy between studies reveals sensitivity of signal detecti **Source:** PMC DAEN analysis, Australia 2025 Australian DAEN database shows exceptionally high ROR (17.66) for dulaglutide eating disorder reports compared to US/Canadian databases, suggesting either: (1) small denominator effects in lower-volume database, (2) population-specific differences in drug response or reporting patterns, or (3) higher clinical awareness/reporting rates in Australian healthcare system. This geographic heterogeneity in signal strength warrants investigation of population-level moderators. + + +## Extending Evidence + +**Source:** FDA Wegovy oral approval label, January 2026 + +FDA oral Wegovy label (January 2026) contains NO eating disorder warning despite known pharmacovigilance signal (aROR 4.17-6.80). Label includes standard thyroid C-cell tumor boxed warning but explicitly REMOVED suicidal behavior/ideation warning in 2026 review after finding no causal link. This regulatory asymmetry—removing psychiatric warnings while maintaining zero ED action despite larger signal—is now documented with the first oral GLP-1 approval. diff --git a/domains/health/glp1-pre-treatment-eating-disorder-screening-recommended-not-required.md b/domains/health/glp1-pre-treatment-eating-disorder-screening-recommended-not-required.md index 3dae8dc8e..ca5a3c319 100644 --- a/domains/health/glp1-pre-treatment-eating-disorder-screening-recommended-not-required.md +++ b/domains/health/glp1-pre-treatment-eating-disorder-screening-recommended-not-required.md @@ -31,3 +31,10 @@ Review explicitly states 'no definitive evidence of the causal relationship betw **Source:** VigiBase 2.06M reports, aROR analysis VigiBase analysis quantifies eating disorder signal magnitude at aROR 4.17-6.80 (4-7x higher reporting odds), the highest psychiatric signal in the study. However, database lacked pre-existing psychiatric condition data, preventing distinction between medicine-induced reactions and indication bias—supporting screening recommendation but not mandate. + + +## Supporting Evidence + +**Source:** FDA Wegovy oral label, January 2026 + +FDA oral Wegovy prescribing information (January 2026) contains zero eating disorder screening requirements or contraindications for ED history. Label focuses on standard GLP-1 class warnings (thyroid tumors, pancreatitis, GI effects) with no behavioral health screening mandate, confirming the screening gap extends to oral formulations despite expanded access. diff --git a/entities/health/wegovy-oral.md b/entities/health/wegovy-oral.md new file mode 100644 index 000000000..e2da8c3cb --- /dev/null +++ b/entities/health/wegovy-oral.md @@ -0,0 +1,49 @@ +--- +type: entity +entity_type: protocol +name: Wegovy Oral (Oral Semaglutide) +parent_company: Novo Nordisk +status: FDA approved +domain: health +--- + +# Wegovy Oral (Oral Semaglutide) + +**Type:** GLP-1 receptor agonist, oral formulation +**Manufacturer:** Novo Nordisk +**Status:** FDA approved January 2026 +**Indication:** Weight management in adults with obesity or overweight + ≥1 comorbidity; cardiovascular risk reduction in adults with CVD + obesity/overweight + +## Overview + +First oral GLP-1 receptor agonist approved for weight management. Eliminates injection barrier that limited injectable semaglutide (Wegovy) adoption. + +## Clinical Evidence + +**OASIS 4 Trial (Phase III):** +- Duration: 64 weeks +- Population: n=307 +- Primary endpoint: Weight loss 16.6% (treatment) vs 2.7% (placebo) with reduced calorie diet + exercise +- Safety: Serious adverse events 3.9% (treatment) vs 8.8% (placebo) +- Common adverse reactions: nausea, vomiting, diarrhea (standard GLP-1 class profile) + +## Regulatory Status + +**FDA Label (January 2026):** +- Boxed warning: Thyroid C-cell tumor risk (standard GLP-1 class warning) +- NO eating disorder warning or screening requirement +- Suicidal behavior/ideation warning REMOVED in 2026 review (no causal link found) +- No contraindications for psychiatric comorbidity or eating disorder history + +## Market Significance + +Oral formulation expands addressable GLP-1 population by eliminating injection barrier. Accelerates trajectory toward mass-market adoption (1-in-8 Americans forecast). + +## Manufacturing + +Novo Nordisk North Carolina facilities. + +## Timeline + +- **2026-01-01** — FDA approval for weight management and cardiovascular risk reduction +- **2026-01-01** — Launch with North Carolina manufacturing capacity \ No newline at end of file diff --git a/inbox/queue/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md b/inbox/archive/health/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md similarity index 97% rename from inbox/queue/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md rename to inbox/archive/health/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md index fc1f950d1..a25ea70c4 100644 --- a/inbox/queue/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md +++ b/inbox/archive/health/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md @@ -7,10 +7,13 @@ date: 2026-01-01 domain: health secondary_domains: [] format: article -status: unprocessed +status: processed +processed_by: vida +processed_date: 2026-05-05 priority: medium tags: [glp-1, semaglutide, wegovy, oral-glp1, fda-approval, oasis4, access, eating-disorder-label] intake_tier: research-task +extraction_model: "anthropic/claude-sonnet-4.5" --- ## Content