MAKE YOUR VOICE HEARD
- Márcio
- Aug 8, 2023
- 2 min read
Sign the NAF form for the FDA to review Troriluzone (Biohaven) data for SCA3
ATTENTION, ATTENTION, WE WILL NEED EVERYONE'S HELP TO GET ANOTHER MEDICINE FOR ATAXIA, THE FIRST FOR SCA3
Biohaven has submitted a request to the FDA to analyze data from the study of the drug Troriluzole for ataxia SCA3.
More information about this clinical trial can be found at
The FDA declined to review the data, claiming the study had failed its initial objectives (which is true). The FDA recommended that Biohaven schedule a Type 2 meeting to discuss the matter. Biohaven believes that Troriluzole is effective in slowing the progression of SCA3 ataxia and is interested in pursuing the FDA approval process.
The National Ataxia Foundation (NAF), a foundation representing ataxia patients in the United States, has created an online form to gather opinions from people with ataxias and their caregivers regarding whether the FDA should be more flexible and agree to review Biohaven's data for Troriruzole. The more people respond, the greater the pressure NAF, along with patients around the world, will put on the FDA to be more flexible and recognize that SCA3 is a serious, degenerative disease for which there is not yet even a drug to slow its progression.
The participation of everyone with ataxia, their family members, and caregivers is important. Everyone should complete the NAF online form (it only has 5 questions). If you have any questions, leave them in the comments or send a message. Come on, this is an opportunity we can't miss!
TRANSLATION OF THE QUESTIONNAIRE TO HELP THOSE WHO HAVE ANY QUESTIONS WHEN COMPLETING IT
1 - Who is sending this form?
[ ] Name
2 - Please indicate your relationship to the ataxia community. I am: [ ] A patient with ataxia [ ] A relative or family member of someone with ataxia [ ] A friend of the ataxia community, advocate, and/or volunteer [ ] A healthcare provider [ ] A caregiver for someone with ataxia [ ] A researcher or scientist [ ] A law firm [ ] Other (please specify)
3 - Do you believe that because of the disabling or life-threatening aspects of SCA3, its relentless progression, and the difficulty of obtaining medical care, you or the person you care for with SCA3 would accept greater uncertainty about whether a medicine works or not? In other words, would you or the person you care for with SCA3 be willing to try a new medicine even if it has a slightly lower chance of benefit? [ ] Yes [ ] No [ ] Other (specify) [ ]
4 - Do you agree with NAF's contention that the FDA should apply greater regulatory flexibility and agree to review Troriruzole's NDA documentation? [ ] Yes [ ] No [ ] Other (specify) [ ]
5 - Write your comments to the FDA regarding their decision not to review the new drug application for Biohaven's Troriruzole. Please share your personal experience that motivated you to provide your opinion on this matter. [ ]
By Márcio Galvão and Amália Maranhão (Director of Abahe), August 8, 2023
[Post published on 08/08/2023 by Márcio Galvão]
