Anvisa and Roche Cancel Elevidys Registration in Brazil

Overview

• Anvisa and Roche announced the cancellation of Elevidys’ conditional registration in Brazil on Monday, Aug. 24, 2026, saying the totality of evidence did not meet the agency’s regulatory requirements.
• The therapy had received conditional approval in December 2024 and its commercialization was suspended in July 2025 while Anvisa evaluated additional safety information.
• Roche must continue long‑term safety monitoring and reporting for patients who received Elevidys in Brazil, primarily those treated between December 2024 and July 2025.
• Safety questions include reports from the United States of two patients who died of acute liver failure after treatment, a development that heightened global scrutiny of the product.
• Elevidys is a single‑dose gene therapy for Duchenne muscular dystrophy that has been priced as high as R$20 million per dose and is not covered by Brazil’s public health system, creating equity and access concerns for families and health authorities.