[CLSTR]
< Back to situations

Monitor this situation.

[SITUATION] · [ACTIVE] · [HEALTH]

2 clusters · 28 sources · 11 days · First seen · Last updated

Duchenne muscular dystrophy drug regulation in Brazil

Overview

In August 2026, Brazil’s National Health Surveillance Agency (Anvisa) issued two significant regulatory decisions regarding treatments for Duchenne muscular dystrophy (DMD).

First, Anvisa approved the registration of Duvyzat (givinostate), an oral medication developed by Multicare Pharmaceuticals. Intended for patients aged 6 and older to be used alongside corticosteroids, clinical studies suggest the drug may slow the loss of motor capacity and preserve muscle function. While approved for commercialization, its availability in pharmacies or the Unified Health System (SUS) remains subject to pricing and further health system evaluations.

Conversely, Anvisa and Roche announced the cancellation of the conditional registration for the gene therapy Elevidys (delandistrogene moxeparvovec). The cancellation, published in the Official Gazette, followed a request from Roche after Anvisa determined that the manufacturer’s data was insufficient to meet regulatory requirements for maintaining conditional authorization. This decision follows a precautionary suspension of the drug’s sale in July 2025, which occurred after reports of acute liver failure in patients treated in the United States.

Elevidys is a high-cost treatment, with estimated prices between R$ 10.6 million and R$ 20 million per dose. Despite the cancellation, Roche remains legally and medically responsible for the continuous monitoring and follow-up of patients who received the treatment between December 2024 and July 2025, including children in clinical studies and existing access programs. In response to these regulatory shifts, the Brazilian Senate’s Human Rights Commission has scheduled a public hearing to discuss the regulatory situation and public policies for rare diseases.

Entities

Anvisa · Brazil · Multicare Pharmaceuticals · FDA · Duvyzat

Claims

What the coverage asserts, and how many sources carry each claim.

Coverage disagrees

Sources make claims that cannot both be true. CLSTR reports the disagreement; it does not decide who is right.

Timeline

  1. about 9 hours ago

    [HEALTH] 28 sources
    Anvisa and Roche cancel Elevidys registration in Brazil

    Anvisa and Roche have canceled the conditional registration of the gene therapy Elevidys in Brazil due to insufficient efficacy and safety data. Roche must continue monitoring previously treated patients.

  2. 11 days ago

    [HEALTH] 3 sources
    Anvisa approves Duvyzat for Duchenne muscular dystrophy

    Anvisa has approved Duvyzat (givinostate) in Brazil, an oral treatment designed to slow motor function loss in patients with Duchenne muscular dystrophy.

Sources

98fmnatal.com.br · acordacidade.com.br · araguaiabrusque.com.br · araucarianoar.com.br · aredacao.com.br · brasil.estadao.com.br · brasil247.com · caririceara.com · chumbogrossomanaus.com.br · destakjornal.com.br · dev.tnonline.com.br · dgabc.com.br · diarioonline.com.br · g37.com.br · gp1.com.br · istoe.com.br · jornaldafronteira.com.br · landscapeinsight.com · maisminas.org · mobile.valor.com.br · mrnews.com.br · obomdanoticia.com.br · radioguaiba.com.br · regiaonoroeste.com · tnonline.com.br · tribunadaserra.com.br · tribunadonorte.com.br · tribunaonline.com.br

This summary has been updated 2 times: see revision history