Soleno Therapeutics Announces Submission and EMA Validation of Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome

Core Insights - Soleno Therapeutics has received validation from the European Medicines Agency (EMA) for its Marketing Authorization Application (MAA) for Diazoxide Choline Prolonged-Release Tablets (DCCR) aimed at treating hyperphagia in patients with Prader-Willi syndrome (PWS) aged four years and older [1][2] - The company estimates approximately 9,500 patients with PWS in key European markets, including the UK, France, Germany, Italy, and Spain, and has been granted Orphan Drug Designation in the EU, which could provide up to 10 years of market exclusivity if approved [2] Company Overview - Soleno Therapeutics is focused on developing novel therapeutics for rare diseases, with its first commercial product being VYKAT XR (diazoxide choline) extended-release tablets, approved by the FDA on March 26, 2025 [3][12] - The company aims to expedite the availability of DCCR to patients in the EU following regulatory approval [2] Product Information - DCCR is indicated for the treatment of hyperphagia in adults and pediatric patients aged four years and older with PWS [6] - The defining symptom of PWS is hyperphagia, which can lead to severe health complications and significantly impact the quality of life for affected individuals and their families [5] Market Potential - The validation of the MAA represents a significant milestone for Soleno in its mission to deliver this therapy to the PWS community in Europe [2] - The potential market opportunity is underscored by the estimated prevalence of PWS, occurring in approximately 1 in every 15,000 live births [5]