Soleno Therapeutics, Inc. (SLNO) Secures EMA Validation for PWS Treatment VYKAT XR

Soleno Therapeutics, Inc. (NASDAQ:SLNO) has achieved a major regulatory milestone as the European Medicines Agency (EMA) validated its Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets (formerly DCCR) to treat hyperphagia in Prader-Willi syndrome (PWS) for patients aged four and older. This follows the recent U.S. FDA approval of the drug, now marketed as VYKAT XR, marking it as the first approved therapy specifically targeting hyperphagia, the most life-limiting symptom of PWS, in both adults and children.

PWS is a rare genetic disorder characterized by insatiable hunger, leading to dangerous food-seeking behaviors and severe health complications. Soleno Therapeutics, Inc. (NASDAQ:SLNO) estimates that about 9,500 PWS patients in the UK, France, Germany, Italy, and Spain could benefit from this therapy if approved in Europe. The company has also secured Orphan Drug Designation in the EU, potentially granting up to 10 years of market exclusivity.

Soleno Therapeutics, Inc. (NASDAQ:SLNO)’s CEO, Dr. Anish Bhatnagar, emphasized the importance of this milestone in expanding access to a much-needed treatment for the PWS community across Europe. The company is working closely with regulators to expedite the availability of the therapy, which has shown promise in addressing a critical unmet need for patients and families.

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