We are thrilled to share that the FDA has approved the first treatment for hyperphagia (excessive hunger) in individuals with Prader-Willi syndrome (PWS). VYKAT XR (previously referred to as DCCR) is now approved for adults and children 4 years of age and older with Prader-Willi syndrome. Soleno Therapeutics expects VYKAT XR to be available in the U.S. beginning in April 2025. This groundbreaking achievement marks a pivotal moment in the journey to provide life-changing therapies for those affected by PWS, and we are proud to have been a part of it.
In 2014, your donations made it possible for FPWR to make a critical investment in the Phase 2 study of DCCR, which helped lay the foundation for its success. We want to extend our deepest gratitude to our generous donors who made this pivotal moment possible. Your support was crucial in driving this research forward and advancing us to this exciting milestone.
We would also like to thank the families who participated in the PATH for PWS study within the Global PWS Registry. The data you provided was essential in showing that individuals with PWS who had not taken DCCR had higher hyperphagia scores compared to those who were part of the Phase 3 study and received DCCR. This critical insight supported Soleno’s conversations with the FDA, helping to pave the way for this approval.
A special thank you to all of the families who participated in the Phase 2 and Phase 3 clinical trials of DCCR. Without your commitment to participate in these clinical trials for PWS, our community would not be able to celebrate this moment.
Finally, our deep gratitude to the team at Soleno Therapeutics for their dedication and perseverance in developing DCCR as a treatment for hyperphagia in PWS. Their commitment to advancing this therapy has been instrumental in reaching this remarkable milestone, and we are deeply grateful for their partnership in improving the lives of those with PWS.
Next Steps For DCCR
We recognize that there are many questions surrounding this approval, such as when DCCR will be available and how to access it. Please know that we are committed to sharing those answers as soon as they become available, and we will keep the community informed every step of the way.
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Celebrate With Us!
We are celebrating and want you to join us!
- April 19 - Omaha NE
- May 1 - Santa Margarita, CA
- May 18 - Dallas, TX
- Additional Locations To Be Announced.
Would you like to add your city to the list? Email us at research@fpwr.org!
