- European Medicines Agency validates Soleno Therapeutics' application for Diazoxide Choline Tablets.
- Potential market exclusivity of up to 10 years due to Orphan Drug Designation in the EU.
- Treatment aims to address hyperphagia in approximately 9,500 Prader-Willi syndrome patients across key European markets.
Soleno Therapeutics, Inc. (SLNO, Financial), a biopharmaceutical company focused on rare diseases, has announced the European Medicines Agency's (EMA) validation of its Marketing Authorization Application (MAA) for Diazoxide Choline Prolonged-Release Tablets. The treatment targets hyperphagia in patients with Prader-Willi syndrome (PWS) aged four years and older. This marks a key step in providing access to around 9,500 PWS patients across the UK, France, Germany, Italy, and Spain.
The treatment, approved by the U.S. Food and Drug Administration (FDA) under the brand name VYKATâ„¢ XR in March 2025, has been granted Orphan Drug Designation in the EU. This designation could potentially provide Soleno with up to 10 years of market exclusivity upon approval, along with other regulatory and financial benefits. The EMA's validation represents a significant milestone in Soleno's commitment to delivering vital therapy options to the PWS community in the EU.
"The validation of our MAA signifies a crucial milestone in our mission to deliver this important therapy to the broader PWS community," commented Anish Bhatnagar, M.D., Chairman and CEO of Soleno Therapeutics. The company intends to collaborate closely with European regulators throughout the review process to expedite the availability of DCCR to patients if approved.
