Milestone's arrhythmia drug nears China approval with new Phase 3 data

Milestone Pharmaceuticals has achieved a significant milestone with its calcium channel blocker, etripamil, in China. The drug, designed to treat paroxysmal supraventricular tachycardia (PSVT), has shown promising results in a late-phase clinical trial, bolstering efforts for regulatory approval in the country. Simultaneously, the U.S. Food and Drug Administration (FDA) is evaluating its potential approval in the United States.

Etripamil is a nasal spray intended for self-administration by patients experiencing PSVT, a condition characterized by unpredictable and sudden increases in heart rate, often surpassing 150 to 200 beats per minute. This can cause considerable distress and requires effective management to revert the heart rate to normal levels.

In a Phase 3 clinical trial conducted in China with 500 participants, etripamil demonstrated significant efficacy. The primary endpoint of the study was the conversion of PSVT to normal sinus rhythm within 30 minutes of administration. An impressive 40.5% of patients treated with etripamil achieved this conversion, compared to only 15.9% of those who received a placebo (p<0.001). The study also met several key secondary endpoints, including conversions to sinus rhythm at 10, 15, 45, and 60 minutes post-treatment.

The safety profile of etripamil in this trial was consistent with previous studies, with no serious adverse events attributed to the drug. These results were communicated in a release issued on Friday, highlighting the drug's potential in managing PSVT effectively and safely.

Milestone’s partner in China, Ji Xing, is actively pursuing regulatory approval for etripamil in the region. Under a 2021 licensing agreement, Ji Xing oversees the drug's development and commercialization in China. This collaboration included an initial payment of $15 million to Milestone, along with an additional $5 million equity investment from RTW Investments.

In parallel developments in the United States, the FDA has accepted Milestone’s New Drug Application (NDA) for etripamil, following the inclusion of data from the company's CARDAMYST trial program. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for March of the following year, indicating when a decision on the drug’s approval is expected.

Milestone's journey towards U.S. approval has not been without challenges. An initial submission was met with a refuse-to-file action in December, necessitating revisions to certain datasets and the reformatting of files. These adjustments were completed earlier this year, leading to the current review process by the FDA.

The positive outcomes of the Phase 3 trial in China add to the growing body of evidence supporting etripamil’s efficacy and safety, positioning Milestone Pharmaceuticals favorably for potential approvals in both China and the United States. The successful management of PSVT with etripamil could offer a significant improvement in the quality of life for patients affected by this unpredictable heart rhythm disorder.

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