Milestone Pharmaceuticals announces plan to resubmit NDA for etripamil

Milestone announced plans to resubmit the New Drug Application for etripamil to the U.S. Food and Drug Administration for paroxysmal supraventricular tachycardia. Following the previously announced receipt of a Refusal to File letter, Milestone held a Type A Meeting with FDA. FDA indicated that the timing of adverse events in question had minimal impact on the overall characterization of the etripamil safety profile. To align with FDA’s guidance, the Company will restructure the data sets that capture timing of reported AEs, reformat certain data files to facilitate FDA’s analyses, and resubmit the NDA. Based on the guidance received during the Type A Meeting, the Company expects that this approach will address the Refusal to File letter from FDA. FDA has not requested that the Company complete additional clinical efficacy or safety trials prior to resubmitting the NDA. The Company expects a standard NDA review period following resubmission of the NDA for etripamil for PSVT, which is planned for 2Q2024. Considering the revised timeline for NDA submission, the Company has undertaken certain cash conservation measures to reduce spend through program deferrals and team restructuring and expects that the Company’s existing cash resources will fund operations into mid-2025, including the expected Prescription Drug User Fee Act date for the NDA resubmission. If FDA approval is granted, the Company expects to receive a $75 million payment under an existing royalty agreement, which is intended to fund the potential commercial launch of etripamil for PSVT.