Anvisa and Roche cancel Elevidys registration in Brazil FAST-MOVING

Elevidys Duchenne Muscular Dystrophy Anvisa Roche gene therapy

Anvisa and the pharmaceutical company Roche have announced the cancellation of the conditional registration for Elevidys, a gene therapy used to treat Duchenne Muscular Dystrophy (DMD). The decision, published in the Official Gazette, follows a request from Roche after determining that the available scientific data regarding the drug's efficacy and safety were insufficient to meet the regulatory requirements for maintaining its temporary authorization in Brazil.

Elevidys, developed by Sarepta Therapeutics and marketed by Roche, is one of the world's most expensive treatments, with costs estimated between R$ 13.6 million and R$ 20 million per single dose. The drug had been subject to regulatory suspension in July 2025 following reports of severe safety concerns, including cases of acute liver failure and death in patients treated in the United States.

Despite the cancellation of the commercial registration, Anvisa emphasized that Roche remains legally obligated to continue the medical monitoring and follow-up of all patients previously exposed to the medication through clinical trials and existing access programs, including Brazilian children who received the treatment between December 2024 and July 2025.

Entities

Anvisa · Brazil · Duchenne muscular dystrophy · Elevidys · Roche · Sarepta Therapeutics

Claims

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

[● 21 SOURCES] Elevidys is indicated for patients with Duchenne Muscular Dystrophy (DMD). maisminas.org · www.obomdanoticia.com.br · destakjornal.com.br · dol.com.br · www.acordacidade.com.br · +16 more
[● 21 SOURCES] Available data from the manufacturer did not meet the regulatory requirements to maintain conditional registration. maisminas.org · www.obomdanoticia.com.br · destakjornal.com.br · dol.com.br · www.acordacidade.com.br · +16 more
[● 21 SOURCES] Anvisa canceled the conditional registration of the drug Elevidys. maisminas.org · www.obomdanoticia.com.br · destakjornal.com.br · dol.com.br · www.acordacidade.com.br · +16 more
[DISPUTED] The cost of a single dose of Elevidys is estimated at approximately R$ 17 million. dol.com.br · www.estadao.com.br · valor.globo.com · dev.tnonline.com.br · jornaldafronteira.com.br · +1 more
[● 21 SOURCES] The cancellation was requested by the pharmaceutical company Roche. maisminas.org · www.obomdanoticia.com.br · destakjornal.com.br · dol.com.br · www.acordacidade.com.br · +16 more
[● 20 SOURCES] The cancellation does not change Roche's obligation to monitor patients previously exposed to the drug. maisminas.org · www.obomdanoticia.com.br · destakjornal.com.br · www.acordacidade.com.br · www.araucarianoar.com.br · +15 more
[● 3 SOURCES] Two patients in the United States died following episodes of acute liver failure after receiving Elevidys. g37.com.br · 98fmnatal.com.br · jornaldafronteira.com.br
[DISPUTED] The cost of a single dose of Elevidys is estimated to be up to R$ 20 million. www.estadao.com.br · 98fmnatal.com.br · jornaldafronteira.com.br