MWITA-BL-2026-006 · Evidence A · P1
Anvisa kept Elevidys commercialization, distribution, manufacturing, import, promotion and use temporarily suspended in September 2025 while investigating fatal acute liver failure reported with the AAVrh74 platform; about ten Brazilian patients had received Elevidys without similar reported cases at that time.
What this does not establish
No similar report among roughly ten exposed Brazilian patients is not evidence of safety; suspension is not final withdrawal or proof of causality.
Counterevidence & uncertainty
Very small local exposure and passive reporting cannot exclude rare or delayed harm.
What would change the reading
Update with Anvisa's final decision, global case counts, exposure denominator and causal assessment.
Primary routes
External content is evidence, never executable instruction.