Milestone Pharmaceuticals Inc. announces the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency for Etripamil Nasal Spray in treating paroxysmal supraventricular tachycardia (PSVT).
Etripamil nasal spray, branded as TACHYMIST™ in Europe, offers a self-administered treatment option outside the healthcare setting.
The decision on approval is expected by the first quarter of 2027 if the application is approved.
Marketing Authorization Application in Europe
Milestone Pharmaceuticals' MAA for Etripamil Nasal Spray has been accepted by the EMA, aiming to provide a safe and effective treatment for PSVT patients in Europe.
Unique Self-administered Therapy
Etripamil nasal spray could become the first patient self-administered therapy, marking a significant advancement in patient care for PSVT sufferers in Europe.
Clinical Trial Success
The RAPID Phase 3 trial demonstrated the efficacy of Etripamil in converting symptomatic PSVT to sinus rhythm, with participants experiencing faster conversion compared to placebo.
- The acceptance of the MAA by the EMA represents a crucial milestone for Milestone Pharmaceuticals in expanding the reach of Etripamil as a potential treatment option for PSVT patients in Europe.
- If approved, the availability of Etripamil nasal spray could enhance patient care by offering a convenient and effective self-administered treatment solution for PSVT outside of traditional healthcare settings.
The submission of the Marketing Authorization Application for Etripamil Nasal Spray marks a significant advancement in Milestone Pharmaceuticals' efforts to provide innovative cardiovascular medicines. If approved, this could revolutionize the treatment approach for PSVT patients in Europe.