Milestone's etripamil nasal spray approved in China for PSVT

Montreal and Charlotte, N.C., Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on innovative cardiovascular medicines, announced that the National Medical Products Administration (NMPA) in China has granted regulatory approval for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults. This approval marks the first regulatory nod for etripamil outside the United States, bringing the novel therapy to an estimated 3 to 6 million Chinese patients affected by the condition.

The NMPA approval, based on data from the global pivotal Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China, triggers a $2.0 million milestone payment to Milestone. Everest Medicines, which holds an exclusive license with Milestone to develop etripamil in Greater China, will lead the commercialization efforts in the region. Milestone is also eligible to receive up to $98.0 million in additional milestones and tiered royalties of up to 18% on future sales of the drug in Greater China.

Etripamil, marketed as CARDAMYST® in the United States, is a self-administered treatment designed to provide rapid relief to adults experiencing PSVT. The drug’s efficacy was demonstrated in the Phase 3 JX02002 study, which showed that etripamil significantly outperformed a placebo in converting PSVT to a normal heart rhythm within 30 minutes (hazard ratio = 3.002, p = 0.0005). The study also found that treatment-emergent adverse events were comparable between the etripamil and placebo groups, with no serious adverse events reported within 24 hours of dosing.

Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, expressed optimism about the approval, stating, "The approval of etripamil nasal spray in China represents an exciting milestone in our mission to help patients worldwide with PSVT. We congratulate Everest on this achievement and look forward to working closely with them to bring this valuable treatment to Chinese patients."

Paroxysmal supraventricular tachycardia affects millions of people in China and the United States. Characterized by sudden, rapid heartbeats, PSVT can be debilitating, causing palpitations, shortness of breath, chest discomfort, and dizziness. Many patients find existing treatment options inadequate, leading them to seek emergency care or undergo invasive procedures. The availability of a rapid, self-administered treatment like CARDAMYST could significantly improve the quality of life for these patients.

Milestone’s CARDAMYST has already been approved in the United States for the conversion of acute symptomatic episodes of PSVT to sinus rhythm. The drug is a novel calcium channel blocker designed to provide on-demand care and patient self-management. Milestone is currently developing etripamil for additional indications, including the control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults.

With the NMPA approval, CARDAMYST is poised to become a significant treatment option for patients in Greater China, offering a potentially life-changing therapy to those affected by PSVT.