Katelin’s Turn is HERE!!!, page-287

Daybue Begins the Journey to Europe!
Posted on January 14, 2025 by melelllan

Photo by BananaStock on Freeimages.com
Acadia Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Trofinetide for the Treatment of Rett Syndrome

This is a welcome announcement for the thousands of families in the EU and Great Britain and with it comes SO MANY questions!

I know many of the questions that people will have (I have them myself!) and the European Medicines Agency is not a particularly easy to read timeline. Timeframes greatly depend upon whether Daybue has “accelerated assessment”, which I believe it does, but I need to check on that. There is a period of 120 days for the initial assessment and up to another 4 months of questions/answers timeframes. I could not see a definitive date from the time the application is submitted to when an answer MUST be given, unlike in the US, when we knew the exact date (baring an unforeseen circumstances).

I’m so curious who will be their manufacturer, but more so I’m interested in what changes in the formula may be needed to get it approved- mainly red dye 40 is banned in most of Europe and I don’t know the policy on the artificial sweeteners that the US has added. And, IF, those changes have to be made, will it cross over to the US so there is a single approved formula.

I do not know if The EMA (European Medicines Agency) approves a drug it HAS to be accepted by all the countries in the EU or if there are additional steps.

I hope to get some of these answers for you in the coming weeks; but, regardless, this is such a HUGE relief to so many and I want to thank Acadia Pharmaceuticals for striving forward to elevate the lives of those around the world who suffer from Rett syndrome.

May we all find hope in this development and look forward to the success of this application in the coming year



https://trailtoatexastrial.wordpress.com/2025/01/14/daybue-begins-the-journey-to-europe/