EP55: Hope, Perseverance, and Soleno's Path to an FDA-Approval for Prader-Willi Syndrome
Update: 2025-08-26
Description
How does the perseverance of a community and the dedication of a pharmaceutical company lead to an FDA-approved treatment?
On this episode of PWS United, Anish Bhatnagar, CEO of Soleno Therapeutics, and Kristen Yen, Senior Vice President of Global Clinical Operations, met with Dorothea Lantz, PWSA | USA’s Director of Community Engagement, to look back on their path to FDA approval for VYKAT XR. VYKAT XR is the first-ever FDA-approved treatment for hyperphagia in individuals with Prader-Willi syndrome 4 years of age and older. Anish, Kristen, and Dorothea discuss the unique obstacles they faced along the way to FDA approval and how the company and our PWS community overcame those hurdles. They also discuss the importance of advocacy in obtaining FDA-approved treatments, the experience of finally receiving approval after a long journey, and how Soleno is ensuring access and affordability to VYKAT XR, while also helping families educate and engage with their medical professionals.
What are Anish and Kristen’s messages of hope for the PWS community? Listen to this episode of PWS United to find out.
Links:
https://www.vykatxr.com/
On this episode of PWS United, Anish Bhatnagar, CEO of Soleno Therapeutics, and Kristen Yen, Senior Vice President of Global Clinical Operations, met with Dorothea Lantz, PWSA | USA’s Director of Community Engagement, to look back on their path to FDA approval for VYKAT XR. VYKAT XR is the first-ever FDA-approved treatment for hyperphagia in individuals with Prader-Willi syndrome 4 years of age and older. Anish, Kristen, and Dorothea discuss the unique obstacles they faced along the way to FDA approval and how the company and our PWS community overcame those hurdles. They also discuss the importance of advocacy in obtaining FDA-approved treatments, the experience of finally receiving approval after a long journey, and how Soleno is ensuring access and affordability to VYKAT XR, while also helping families educate and engage with their medical professionals.
What are Anish and Kristen’s messages of hope for the PWS community? Listen to this episode of PWS United to find out.
Links:
https://www.vykatxr.com/
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