Milestone Pharmaceuticals recently announced that China’s National Medical Products Administration (NMPA) has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults. Etripamil, marketed in the US as CARDAMYST nasal spray, is a self-administered treatment for adults with PSVT.

The NMPA decision marks the first regulatory approval of etripamil outside the US and triggers a USD 2 million milestone payment to Milestone Pharmaceuticals. Everest Medicines has an exclusive license with Milestone to develop etripamil nasal spray in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).

Under the License Agreement with Everest, Milestone is also eligible to receive up to USD 98 million in commercial and development milestones and tiered royalties of up to 18 percent on future sales of etripamil in Greater China.

The NMPA approval was based on data from the global pivotal phase 3 RAPID study and the phase 3 JX02002 study conducted in China.

JX02002 met its primary endpoint, demonstrating that etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment (hazard ratio = 3.002 [95 percent CI: 1.578, 5.711]; p = 0.0005).

Overall, treatment-emergent adverse events were comparable between the etripamil and placebo groups, and no serious adverse events were reported within 24 hours after dosing across phase 3 studies.

Joseph Oliveto, President and Chief Executive Officer (CEO), Milestone Pharmaceuticals, said, “We believe the approval of etripamil nasal spray in China represents exciting progress toward our vision to help patients around the world living with PSVT. We congratulate Everest on this achievement and look forward to continued collaboration as they launch the product in this important market.”