The National Health Surveillance Agency (Anvisa) and the pharmaceutical company Roche announced the cancellation of the registration of the drug Elevidys, one of the most expensive therapies available globally. The decision was communicated on August 24, 2026 and is based on the absence of data that fully meets the regulatory standards required by the authority. Elevidys (delandistrogen moxeparvoveque) is indicated for the treatment of Duchenne muscular dystrophy (DMD).

The reasons behind Elevidys suspension

The central reason for the cancellation of Elevidys’ registration, as reported by Anvisa, lies in the lack of information that meets the body’s strict regulatory criteria. This type of evaluation is crucial to guarantee the safety and effectiveness of medicines before and during their commercialization in Brazil.

Full coverage: Latest News (EN)

Monitoring patients who have already received treatment

Even with the suspension of registration, the National Health Surveillance Agency clarified that the measure does not exempt Roche from its obligations. The company must continue monitoring patients who participated in clinical studies and programs, including Brazilians who received Elevidys between December 2024 and July 2025, ensuring continuous safety monitoring and sending relevant information to Anvisa, in accordance with current legislation.

Understand Duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD) is a rare, progressive genetic condition that causes muscle weakness and gradual loss of function. The disease is caused by a change in the DMD gene, which prevents the production of dystrophin, a protein essential for muscle integrity. Elevidys was developed as a gene therapy to try to correct this deficiency.

Implications of cancellation for treatment in Brazil

Considered one of the most expensive medicines in the world, the deregistration of Elevidys raises important questions about access to innovative and high-cost treatments for rare diseases in Brazil. Anvisa’s decision highlights the agency’s priority in ensuring that only therapies with robust safety and efficacy data are made available to the population.