Pressure on the FDA
- Márcio
- Sep 21, 2023
- 1 min read
On this website, you can download the 92-page report that the NAF (National Ataxia Foundation), an association of ataxia patients in the USA, sent to the FDA, requesting greater flexibility and speed in the review of ataxia medications. Last month, the FDA refused to review data submitted by the American pharmaceutical company Biohaven regarding the drug Troriruzole, which supposedly can help reduce the progression of SCA3 ataxia. This sparked a worldwide outcry, and people from 52 different countries (ataxia patients, relatives, caregivers, friends, doctors, researchers, etc.) participated in a campaign coordinated by the NAF in the USA (and by Abahe – Brazilian Association of Hereditary and Acquired Ataxias in Brazil) to request greater regulatory flexibility for the FDA in the case of rare, degenerative, and as-yet incurable genetic diseases. The result is the report that was sent to the FDA. Now, we wait to see if the FDA agrees to evaluate the drug. The page is in English, but it is possible to enable translation into Portuguese.
[Post published on 09/21/2023 by Márcio Galvão]
