We know that many families across our community are feeling frustrated, disappointed, and even angry following the recent news regarding Vykat XR and the withdrawal of the European application
As parents ourselves, we want to start by saying clearly:
We feel this too.
We understand how much hope has been placed in this treatment, and how difficult it is to feel that progress has stalled.
What we know right now
At this stage:
- The treatment has been approved by the FDA in the United States
- The application to the European Medicines Agency (EMA) has been withdrawn
- There has not yet been an application to the MHRA in the UK
For many families, progress through the EMA had been seen as a potential step towards access in the UK, so this development is understandably very disappointing.
It is important to clarify that this is not a refusal of the treatment in the UK or Europe, but rather there is currently no active regulatory process in Europe, and no application under review.
Why this matters
For families living with Prader-Willi syndrome, this is not just about process — it is about daily life.
The need for effective treatments, particularly for hyperphagia, is urgent and real. Waiting is incredibly hard, especially when a treatment is available elsewhere.
Where this leaves us
We are currently in a period of transition:
- The company behind the treatment (Soleno Therapeutics) is being acquired by Neurocrine Biosciences
- There is currently no confirmed information on regulatory plans or next steps
- There are no confirmed timelines available
We remain in contact with the relevant organisations and have requested further information. We will share updates as soon as we are able.
What can be done right now
We have seen a strong reaction from the community, including discussions around petitions and coordinated advocacy. This passion and determination is incredibly important and amazing to see.
However, at this moment:
- There is no active UK or European regulatory decision to influence
- The situation is still evolving, and key information is not yet available
This means that immediate actions like petitions may not yet have a clear target or impact.
Where your voices matter most
While we wait for clarity, there are still meaningful ways the community can make a difference:
- Sharing lived experiences of PWS and hyperphagia
- Raising awareness of the day-to-day realities families face
- Highlighting unmet need clearly and consistently
This kind of evidence will be vital when future applications are considered, helping decision-makers fully understand the urgency and impact. Having this information prepared now will help us act more quickly and effectively when opportunities to influence future decisions arise.
Our role as FPWR UK
FPWR UK exists to support and drive research that leads to meaningful treatments for people with PWS.
We work closely with international partners, researchers, and industry to:
- Fund and support promising research
- Advocate for progress
- Represent the voices of UK families
We want to reassure our community that:
- We are actively engaged in this situation
- We are seeking answers
- We will continue to advocate for UK access to treatment
We are not standing still — but we do need to understand the landscape before taking the next steps.
Working together as a community
We know there is a strong desire across the community to take action, and we share that drive to make a difference.
As soon as we have a clearer understanding of the situation, and a defined route where the community can have meaningful influence, we will put out a call to action and coordinate next steps.
In the meantime, we are very open to hearing suggestions from families — whether that is around advocacy, collaboration with European organisations, petitions, or other ideas.
However, it is important that we take a little time to consider each option carefully and ensure that any action is well-informed, targeted, and has the best possible chance of making a real impact.
At this stage, having a clearer understanding of the current landscape is essential before determining the most effective course of action.
A message to our community
We know how hard it is to be patient right now, and how urgent the need feels.
Please be assured:
- Your voices are being heard
- Your frustration is valid
- Your determination to push for change is shared by us
As a community, we are strongest when we are informed, coordinated, and focused on the actions that will have the greatest impact.
What happens next
We will continue to:
- Engage with key stakeholders
- Seek clarity on future plans
- Keep our community updated as soon as we have confirmed information
We are incredibly grateful for the way families are coming together, supporting one another, and continuing to push for progress.
If you would like to be more involved in supporting FPWR UK’s work — whether through sharing your story, raising awareness, or volunteering — we would very much welcome you.
We are in this together.
To get in touch we are available to message on our social media channels, Facebook, Instagram, LinkedIn and TikTok and also by email to info@fpwr.org.uk