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Milestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States

MIST
  • China's National Medical Products Administration (NMPA) approved etripamil nasal spray for treating paroxysmal supraventricular tachycardia (PSVT) in adults, marking the first regulatory authorization of the drug outside the United States.
  • Everest Medicines holds an exclusive license with Milestone Pharmaceuticals to commercialize etripamil in Greater China, targeting an estimated 3-6 million patients in the region.
  • The NMPA approval triggered an immediate $2.0 million milestone payment to Milestone Pharmaceuticals.
  • Under the licensing agreement, Milestone is eligible for up to $98.0 million in additional development & commercial milestones and tiered royalties of up to 18% on future sales in the region.
  • The approval was supported by data from the global Phase 3 RAPID study & the China-based Phase 3 JX02002 study, which showed etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes.
  • Clinical trials demonstrated comparable treatment-emergent adverse events between etripamil & placebo groups, with no serious adverse events reported within 24 hours of dosing.
  • In the United States, the drug is marketed as CARDAMYST® nasal spray & is indicated for the conversion of acute symptomatic PSVT episodes to sinus rhythm in adults.
  • Potential side effects of CARDAMYST include nasal discomfort, congestion, runny nose, throat irritation, nosebleeds, & fainting due to effects on blood pressure or heart rate.
  • Contraindications for CARDAMYST include allergies to ingredients, moderate to severe heart failure, Wolff-Parkinson-White syndrome, sick sinus syndrome without a pacemaker, & second-degree or higher AV block.
  • Milestone Pharmaceuticals is currently conducting Phase 2 trials for pediatric PSVT & Phase 3 trials for acute atrial fibrillation with rapid ventricular rate (AFib-RVR).