In a disappointing decision, the FDA has stated that they will not review DCCR for the treatment of PWS without an additional controlled clinical trial. (Read more about this recent news in our blog: FDA requires additional trial to support NDA submission for DCCR in PWS.) This decision could cost us years, or worse, the loss of a potential treatment for our loved ones.
The most effective voice in making change is yours, so FPWR and PWSA | USA are asking members of the PWS community to sign-on a letter to the FDA requesting that the FDA re-review the results of Soleno's Phase 3 study of DCCR for the treatment of PWS. In the sign-on we request that you share how a treatment for PWS could be impactful to your loved one and your family and if you participated in the trial, please share treatment experience! Responses provided by the community through this sign-on will be collectively shared with the FDA as we continue to advocate for new safe and effective treatments for our loved ones.
Many of you have participated in the surveys and studies we have done to help the FDA understand our community’s perspective on what treatments are needed, the level of risk families are willing to accept, and the impact of COVID-19 on our kids. As you know all too well, there are currently NO treatments the most challenging aspects of PWS. We believe that the tremendous unmet medical needs of our children and adults with PWS, as well as the profound impact of COVID-19 on PWS clinical trials, should be taken into account when considering next steps for DCCR.
Your action is imperative to our success. Sign-on to our letter to make sure your voice is heard and we will keep you abreast of any news and next steps.