First Gene Therapy Products Approved in Brazil

Brazil has become the first among the Latin American countries to approve the marketing of gene therapy products. Specifically, the Brazilian Health Regulatory Agency (ANVISA) recently granted marketing authorization for Novartis’ gene therapy products Luxturna® and Zolgensma®. As published in the Brazilian Federal Register, Luxturna® received its marketing authorization on August 6th and a few days later, on August 17th, Zolgensma® received its marketing authorization. Prior to ANVISA’s final decision, both products had been approved by the Brazilian Technical Commission of Biosafety (CTNBio), which is responsible for evaluating biosafety of Genetically Modified Organisms (GMOs) in Brazil.


By Lisa L. Mueller via Lexology


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