EMA accepts Milestone Pharmaceuticals’ MAA for etripamil nasal spray for the treatment of PSVT

Milestone Pharmaceuticals announced that the European Medicines Agency has accepted the company’s marketing application for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT), with a decision expected in early 2027. If approved, the etripamil nasal spray would be marketed in Europe as Tachymist.

Etripamil nasal spray was recently approved in the US for the treatment of PSVT in adults, under the brand name Cardamyst. Milestone is also developing etripamil for the treatment of PSVT in pediatric patients and for the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR). 

Milestone Pharmaceuticals President and CEO Joseph Oliveto commented, “Following guidance from the EMA, this MAA incorporates the global clinical data package that supported the US Food and Drug Administration approval of etripamil for the treatment of PSVT. Tachymist could become the first approved patient self-administered therapy representing a meaningful step forward in patient care for the approximately two million people suffering from PSVT in Europe.”

Read the Milestone Pharmaceuticals press release

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