Anvisa Cancels Registration of Elevidys, Medicine of R$ 20 Million and One of the Most Expensive in the World
8 Articles
8 Articles
The National Agency for Health Surveillance (Anvisa) and the pharmacist Roche cancelled the registration of the medicine Elevidys (delandistrogen moxeparvoveque), considered one of the most expensive in the world. The reason for the decision, published on Monday (24), was based on the lack of data that meet the regulatory requirements of the authority.
Decision responds to manufacturer's request after insufficient data on efficacy and warnings of hepatic impairment in patients
The pharmacist requested cancellation after insufficient data to keep the medicine record
Anvisa (Agncia Nacional de Vigilncia Sanit ria) cancelled on Monday (24) the conditional registration of the medicine Elevidys (delandistrogen moxeparvoveque), the general therapy used in the treatment of Duchenne muscular dystrophy (DMD). The request started from the manufacturer Roche, says the agency, and the decision was published in the Dirio Oficial da Unio. Read more (08/24/2026
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A TribunaThe National Agency for Health Surveillance (Anvisa) and Roche notified on Monday (24) the cancellation of the conditional registration of the medicine Elevidys® (delandistrogen moxeparvoveque), at the request of the pharmacist. The conditional registration is a temporary authorization for the use or marketing of a product in the country. The measure was published in the Official Journal of the Union. The interruption was adopted after the under…
The National Agency of Health Surveillance (Anvisa) cancelled, on Monday (24) the registration of the Elevidys (delandistrogen moxeparvovec), gene therapy aimed at the treatment of the muscular dystrophy of Duchenne (DMD). Considered one of the most expensive medicines in the world, with an estimated cost of R$ 20 million in single dose, the product was not incorporated into the Unified Health System (SUS) and had been obtained in the country th…
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