Posted by Michael Wonder on 23 May 2025
Soleno Therapeutics announces submission and EMA validation of marketing authorisation application for diazoxide choline prolonged release tablets for the treatment of hyperphagia in patients with Prader-Willi syndrome
22 May 2025 - Soleno Therapeutics today announced that Soleno’s marketing authorisation application seeking regulatory approval of diazoxide choline prolonged release tablets for the treatment of adults and children four years and older with Prader-Willi syndrome who have hyperphagia had been validated by the EMA.
The Company has been granted orphan drug designation for diazoxide choline in the EU for the treatment of Prader-Willi syndrome, which could provide Soleno with up to 10 years of market exclusivity in the EU, if approved, in addition to certain other regulatory and financial incentives.
