dofetilide IV / Hyloris Pharma - LARVOL DELTA

Hyloris Announces Positive Study Results for Dofetilide IV (Hyloris Press Release) - "Hyloris Pharmaceuticals SA ...announces positive results from a pivotal clinical study evaluating its proprietary Dofetilide IV. The study was designed to compare bioavailability between the intravenous (IV) and oral form of the drug (dofetilide) and to establish optimal dosing strategies, including the initial dose and timing to transition to oral therapy. This key milestone supports the submission of a New Drug Application (NDA) of Dofetilide IV to the U.S. Food & Drug Administration (FDA) planned in the next months....'Currently, patients starting dofetilide therapy typically require multiple days of hospitalization to ensure safe dosing and monitoring, primarily due to the need for gradual dose titration and continuous QT interval monitoring.'....The data generated will be critical for regulatory submission and will help define best practices for Dofetilide IV use in real-world clinical settings."

Real-world • Cardiovascular