Milestone Gets China Approval For Etripamil Nasal Spray

(RTTNews) - Milestone Pharmaceuticals (MIST) on Thursday announced that China's National Medical Products Administration has approved etripamil nasal spray for treating paroxysmal supraventricular tachycardia (PSVT) in adults. Etripamil is marketed in the U.S. as CARDAMYST.

The approval marks the first regulatory approval for etripamil outside the United States and triggers a $2 million milestone payment to Milestone. Everest Medicines holds an exclusive license to develop etripamil in Greater China, including mainland China, Hong Kong, Macau and Taiwan. Milestone is also eligible for up to $98 million in commercial and development milestones, along with tiered royalties of up to 18% on future Greater China sales.

The approval was supported by data from the global Phase 3 RAPID study and China's Phase 3 JX02002 study. JX02002 met its primary endpoint, with etripamil significantly outperforming placebo in converting PSVT to sinus rhythm within 30 minutes, with a hazard ratio of 3.002 and p=0.0005.

Milestone said an estimated 3 million to 6 million people in China are diagnosed with PSVT. The company plans to continue working with Everest Medicines as it launches etripamil in the Chinese market.