Friedreich's ataxia drug approved in Europe

On February 12, 2024, the European Medicines Agency (EMA) announced that it had approved the drug Skyclarys® (Omaveloxolone) from the pharmaceutical company Biogen for the treatment of Friedreich's ataxia in adults in the countries of the European Union.

Omaveloxone has shown positive results in preclinical laboratory tests and also in clinical trials with human patients (MOXIe trial). The drug's trade name in the United States is SKYCLARYS®. In February 2023, SKYCLARYS was approved by the FDA for marketing in the United States, and now, in February 2024, the drug is also approved for marketing in countries of the European Union.

For Brazilian patients with Friedreich's ataxia, the battle to bring the medication to Brazil continues, requiring review and approval from ANVISA. Friedreich's ataxia is a rare, neurodegenerative, and disabling genetic disease. Amália Maranhão , Director of Abahe (Brazilian Association of Hereditary and Acquired Ataxias), is at the forefront of this effort.

Learn more about Friedreich's ataxia at https://www.ataxia.info/ficha-fa

Learn more about SKYCLARYS at https://www.ataxia.org.uk/omav-updates/

[Post published on 02/12/2024 by Márcio Galvão]